11-9199.01 - Regulatory Affairs Managers
Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.
- Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
- Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
- Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
- Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
- Develop regulatory strategies and implementation plans for the preparation and submission of new products.
- Establish regulatory priorities or budgets and allocate resources and workloads.
- Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.
- Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
- Maintain current knowledge of relevant regulations, including proposed and final rules.
- Manage activities such as audits, regulatory agency inspections, or product recalls.
- Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.
- Participate in the development or implementation of clinical trial protocols.
- Provide responses to regulatory agencies regarding product information or issues.
- Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.
- Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
- Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.
- Train staff in regulatory policies or procedures.
- Contribute to the development or implementation of business unit strategic and operating plans.
- Coordinate internal discoveries and depositions with legal department staff.
- Develop and maintain standard operating procedures or local working practices.
- Establish procedures or systems for publishing document submissions in hardcopy or electronic formats.
- Evaluate new software publishing systems and confer with regulatory agencies concerning news or updates on electronic publishing of submissions.
- Develop relationships with state or federal environmental regulatory agencies to learn about and analyze the potential impacts of proposed environmental policy regulations.
- Monitor regulatory affairs activities to ensure their alignment with corporate sustainability or green initiatives.
- Direct documentation efforts to ensure compliance with domestic and international regulations and standards.
- Evaluate regulatory affairs aspects that are specifically green, such as the use of toxic substances in packaging, carbon footprinting issues, or green policy implementation.
- Monitor regulatory affairs trends related to environmental issues.
Clicking on the Degree programs in the list below will take you away from the Careers page.
The curriculum is designed for persons who seek employment in the accounting field or for those presently in accounting who wish to increase their knowledge and update their skills. Job opportunities include accounting trainee, accounting technician, junior accountant, and accountant.
This degree is excellent for those interested in the organization and reporting of financial data. Upon completion of the program, students can take an additional three courses for the Accounting Career Studies Certificate, and then are eligible to proceed to the CPA exam, if other education requirements are satisfied. Contact the Virginia Board of Accountancy for all education requirements.
The curriculum is designed for individuals who seek employment in business management or for those presently in management who are seeking promotion. Job opportunities include administrative assistant, management trainee, department head, branch manager, office manager, manager of small business, and supervisor.
This curriculum is designed for individuals who plan to seek employment in contract management positions and for those presently in contract management positions who seek career advancement. The program is designed to create opportunities for positions in contract management for both government agencies and private industry. Instruction includes both the theoretical concepts and the practical applications needed for future success in the contract management field. This will provide a greater understanding of acquisition, life cycle management, and contracting processes. Job opportunities include project manager, procurement analyst, contract administrator, contract specialist, contract negotiator, contract price analyst, and contract termination specialist.
The curriculum is designed to provide a broad foundation that will prepare students to enter any of the varied fields in criminal justice or to prepare for professional advancement. Job opportunities for students include local, state, and federal enforcement officers, police officers, private or government investigators, adult/juvenile correction officers, probation/parole officers and counselors, security directors (managers), loss prevention directors, classification managers, and personnel clearance administrators. Most of the ADJ courses in this curriculum are 'core courses' that provide a basic entry-level foundation in both criminal justice and security administration. These courses must be taken by ALL STUDENTS in this program. At several points in the curriculum, 'course options' are provided for selection by the students.
Special Curriculum Admission Requirements: Students are advised that many criminal justice and private/government security agencies require excellent moral character and a written record of conduct prior to consideration for employment.
This program prepares students for entry-level opportunities as a local, state, or federal law enforcement officer; commercial and industrial security officer; police officer; or private or government investigator, particularly in the areas of homeland security.
This program is designed for individuals who plan to transfer to a four-year institution to complete a bachelor of arts (B.A.).
This program is designed to prepare students who intend to transfer to a four-year institution to complete a bachelor's degree in international studies. This specialization will broaden the student's education to include more emphasis on other cultures and countries in recognition of the increasing interdependence of today's world.
This curriculum is designed for individuals who plan to transfer to a four-year college or university to complete a baccalaureate degree program in business administration with a major in accounting, business management, decision science and management, information systems, finance, marketing, etc.
This program is designed to prepare students to transfer to a four-year college or university to complete a baccalaureate degree program in criminal justice, criminology, or related fields.
This curriculum is designed for students who plan to transfer to a college or university for a BS or B.A. degree in psychology.
This program is a flexible associate degree. For students who plan to transfer, the degree can parallel the first two years of a four-year bachelor of science program if they choose courses that match the transfer institution's requirements. For those students who do not plan to transfer, the degree allows them to structure a program to suit their needs using accumulated credits from a variety of formal and experiential sources.
This program is designed for individuals who plan to transfer to a four-year college or university to complete a bachelor of science in one of the social sciences. It also prepares students for some teacher certification programs. Students from the A.S. program major in a wide variety of fields, including anthropology, economics, government/political science, history, mass communications, pre-law, psychology, public administration, social work, and sociology.
This curriculum prepares students to transfer to a four-year college or university teacher preparation program. It is specifically designed for students who plan to seek endorsement and licensure as teachers in PK-3, PK-6, middle school, or special education.
This degree program is designed to help students earn all of the required endorsement course hours for a teaching license in elementary education for the state of Virginia. In addition, this degree program includes many of the required endorsement courses for licensure in middle school (any subject) and high school history and social sciences. Some of these universities will guarantee admission to graduates of this program who have a cumulative GPA of at least 2.5, earn at least a 'C' in all English courses. Students are strongly encouraged to take the VCLA exam shortly after completing their 200-level English course. Students may want to take the Praxis CORE math exam after completing 9-12 hours of mathematics. The student, working directly with a NOVA Teacher Education Specialization advisor/counselor, should complete a transfer letter of agreement.
This program is designed for individuals who plan to transfer to a four-year college or university to complete a bachelor of science in a program that requires a background in American Sign Language and the Deaf community. Graduates may use their skills to work in human service fields such as daycare settings and as teacher assistants. Graduates from the program can also transfer to 4-year institutions and major in a wide variety of fields, including ASL instruction, Deaf education, linguistics, Deaf studies (e.g. history, literature, research, etc.), speech-language pathology and audiology, human services, communication sciences and disorders, and social work.
This program is designed for individuals who plan to transfer to a four-year college or university to complete a baccalaureate degree. Graduates will have the knowledge, skills, and abilities equivalent to students entering the junior level at four-year colleges and universities.
This program is designed to prepare students to transfer into baccalaureate programs in the geospatial or social sciences at a four-year institution. Students will learn theory about geospatial systems and how they are used.
This program is designed to prepare students to start and grow a successful small business by providing instruction in entrepreneurial culture, strategy, operations, financial management, marketing, and leadership.
This program is designed to help students develop both the theoretical knowledge and a practical facility with GIS. Students who already hold a baccalaureate or master's degree will acquire the requisite skills and knowledge to switch careers, or to apply spatial analysis in their present workplaces. Students will be positioned to pursue additional coursework toward an associate degree and/or transfer to a four-year institution for further study in the geospatial, environmental, or physical sciences; in civil engineering; in information technology; or in business/marketing at a four-year institution.
Preparation: Students are expected to understand fundamental computer applications and concepts before enrolling in GIS courses.
The certificate programs provide course work that gives students the skills to sit for one or more certification exams administered by the Accreditation Council for Accountancy and Taxation (ACAT).
Students planning to pursue a B.S. in Business Administration from a four-year college/university are advised to pursue TCC's general A.S. degree in Business Administration (plan code 213).
Clicking on a Job in the list below will take you away from the Careers page.
|Regulatory Affairs Analyst||Rodan and Fields, LLC||Thu, 19 May 2022 18:11:59 GMT | 30+ days ago||San Francisco Bay Area, CA||5+ years of regulatory experience in the cosmetics, or consumer goods industries. Generation of regulatory information packages for cosmetic and OTC formulas…|
|Manager, Regulatory Affairs||Hurley Consulting Associates||Mon, 27 Jun 2022 21:15:56 GMT | 6 days ago||Summit, NJ 07901||Preparation and maintenance of regulatory files. Preparation of regulatory submissions including INDs and IND amendments.|
|Regulatory Affairs Specialist – Irvine, CA, (Remote or hybrid)||BD||Thu, 26 May 2022 13:22:06 GMT | 30+ days ago||Irvine, CA||Maintains regulatory databases/systems for key regulatory data. Additionally, the position will provide regulatory support to marketed products and ensure…|
|Regulatory Affairs Specialist||Philips||Thu, 21 Apr 2022 21:49:17 GMT | 30+ days ago||Bothell, WA||Reviews protocols and reports to support regulatory submissions. Supports necessary regulatory activities required for product market entry.|
|Regulatory Affairs Specialist 1||Arbonne||Sat, 21 May 2022 02:08:43 GMT | 30+ days ago||Irvine, CA 92630||Create and implement strategies with Manager or with multifunctional teams for international regulatory submissions.|
|CMC Regulatory Affairs - Manager - Remote Position||Freyr||Fri, 20 May 2022 18:36:12 GMT | 30+ days ago||Remote||O Demonstrate an understanding of regulatory affairs and apply this understanding to ensure approval and product supply continuity.|
|Regulatory Affairs Manager - Remote||Lumen||Fri, 01 Jul 2022 01:14:08 GMT | 3 days ago||Remote||5 years’ government affairs or regulatory experience. The Regulatory Affairs Manager is critical to the regulatory and government affairs organization and works…|
|Regulatory Affairs Manager||Katalyst Healthcares & Life Sciences||Wed, 30 Mar 2022 02:12:04 GMT | 30+ days ago||Madison, NJ 07940||Pertinent Federal and State laws related to pharmaceutical regulatory affairs. Works to minimize regulatory issues and helps prevent unnecessary regulatory…|
|Regulatory Affairs Engineer||Promega||Wed, 01 Jun 2022 10:10:09 GMT | 30+ days ago||Madison, WI 53711||Support internal and external audits and regulatory inspections. Strong attention to detail and sound ability to interpret, translate and address regulatory…|
|Manager, Regulatory Affairs||Bausch + Lomb||Thu, 30 Jun 2022 07:30:19 GMT | 3 days ago||Santa Fe, NM 87501||The Manager is responsible for the regulatory CMC strategy of all submissions and managing interactions with regulatory authorities on CMC issues.|
|Manager of Regulatory Affairs||HAWAIIAN TELCOM||Sat, 14 May 2022 02:27:47 GMT | 30+ days ago||Honolulu, HI 96821||This position researches and analyzes federal and state regulatory issues and orders, provides development and implementation support for regulatory aspects of…|
|Regulatory Affairs Associate-11834||Leadstack Inc||Fri, 01 Jul 2022 23:40:33 GMT | 2 days ago||Foster City, CA 94404||Develop and maintain knowledge of regulatory requirements independently and with line manager. Assess change controls for regional regulatory impact and record…|
|Regulatory Affairs Reporting Officer||Credit Suisse||Thu, 17 Feb 2022 01:06:43 GMT | 4 months ago||New York, NY||In addition, applicant would collaborate with regulatory affairs coverage officers to keep tabs on recent interactions. Including hot topics and themes.|
|Manager Regulatory Affairs||Laborie Medical Technologies||Sat, 28 May 2022 09:15:06 GMT | 30+ days ago||Minnetonka, MN||Manage the daily operations of the Regulatory Affairs department for GI, including management of the regulatory affairs specialists.|
|Manager Regulatory Affairs - AMD||Abbott Laboratories||Thu, 02 Jun 2022 01:32:03 GMT | 30+ days ago||Des Plaines, IL||Individual is recognized as a discipline expert and resource in regulatory affairs. Ethical guidelines of the regulatory profession, clinical research and…|
|Senior Manager, Regulatory Affairs -AD Promo||Sun Pharmaceutical Industries, Inc (USA)||Wed, 08 Jun 2022 02:12:47 GMT | 26 days ago||Princeton, NJ||Ensure full regulatory compliance of all promotions with approved labeling and /or FDA guidance’s. Actively participate in MLR discussion and provide strategic…|
|REGULATORY AFFAIRS SPECIALIST - CUSTOMER DEDICATED (FSP) CONTRACT OPPORTUNITY||PPD||Tue, 16 Mar 2021 23:36:55 GMT | 15 months ago||Wilmington, NC 28401||Basic knowledge of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management…|
|Regulatory Affairs Manager||Bioventus||Wed, 22 Jun 2022 18:14:05 GMT | 11 days ago||Memphis, TN||Liaises with project teams to develop regulatory strategies, testing requirements and other documentation to ensure regulatory data requirements are met.|
|Manager, Regulatory Affairs and Compliance||Aldevron||Thu, 30 Jun 2022 22:58:52 GMT | 3 days ago||Fargo, ND 58102||Regulatory affairs experience is required. Responsible for training, mentoring, and coaching internal personnel including the regulatory affairs staff on…|
|Manager, Regulatory Affairs CMC||Gilead Sciences||Mon, 03 Jan 2022 23:36:32 GMT | 6 months ago||Foster City, CA||Knowledge of regulatory requirements related to chemistry, manufacturing and control (CMC), including ICH requirements and regional requirements and have an…|
|Regulatory Affairs Specialist||Katalyst Healthcares & Life Sciences||Thu, 28 Apr 2022 23:11:55 GMT | 30+ days ago||Richmond, VA||Familiarity with pharmaceutical development and global regulatory submissions. Experience in document management and regulatory publishing is required.|
|Regulatory Affairs Associate(Submission Management/ Publishing experience)||Tellus Solutions||Wed, 01 Jun 2022 00:11:44 GMT | 30+ days ago||Remote||Typically reports to a manager or head of a unit/department. Responsible for filing necessary applications and handling all government interactions pertaining…|
|Regulatory Specialist||University of California San Francisco||Thu, 19 May 2022 04:47:37 GMT | 30+ days ago||San Francisco, CA 94143||A recognized expert in broad-based healthcare industry regulatory affairs or a specialty area, especially involving Joint Commission accreditation standards.|
|Senior Regulatory Affairs Specialist - Cardiac Surgery (remote)||Medtronic||Thu, 12 May 2022 16:38:10 GMT | 30+ days ago||Mounds View, MN||Minimum of 4 years of experience in regulatory affairs in the medical device industry. Work with RAS, engineers and technical experts to resolve potential…|
|Director of Regulatory Affairs and Quality Assurance||Minnetronix||Tue, 10 May 2022 20:24:58 GMT | 30+ days ago||Saint Paul, MN 55108||Provides regulatory strategy both internally and for customers to move through the regulatory process in the most appropriate path.|
|Senior Regulatory Affairs Manager- Rochester, NY, Raritan, NJ or Remote||Ortho Clinical Diagnostics||Thu, 09 Jun 2022 14:28:14 GMT | 24 days ago||Rochester, NY 14626||Responsible for the 1 over 1 final review of critical regulatory documents planned for regulatory submissions and responses to regulatory agencies as needed.|
|Regulatory Affairs Project Manager||Abbott Laboratories||Thu, 19 May 2022 01:32:16 GMT | 30+ days ago||Lake Forest, IL||Reviews U.S. regulatory aspects of contracts. Provide regulatory input to product lifecycle planning. Participates in risk benefit analysis for regulatory…|
|Counsel, Regulatory Affairs||MasterCard||Wed, 16 Mar 2022 04:02:01 GMT | 30+ days ago||Purchase, NY 10577||Coordinate regulatory examinations and management responses. Experience in banking and/or lending regulatory compliance. Bachelor’s degree is required.|
|Senior Manager, Regulatory Affairs -AD Promo||Sun Pharmaceutical Industries, Inc.||Tue, 07 Jun 2022 23:19:18 GMT | 26 days ago||Princeton, NJ||Ensure full regulatory compliance of all promotions with approved labeling and /or FDA guidance’s. Actively participate in MLR discussion and provide strategic…|
|Counsel, Regulatory Affairs||Cox Enterprises||Fri, 22 Apr 2022 23:36:40 GMT | 30+ days ago||Washington, DC||You’ll learn about new issues and have to assess existing regulatory matters. You’ll maintain organization for pending FCC-related work items and assist in…|
|Regulatory Affairs Associate Specialist, ( Dallas -Fort Worth Metropolitan Area)||McKesson||Thu, 30 Jun 2022 02:21:49 GMT | 4 days ago||Dallas-Fort Worth, TX||This will require collaboration with internal partners, regulatory affairs team members, and customers. Experience in controlled substance regulatory compliance…|
|Senior Regulatory Specialist||Arbonne||Thu, 27 Jan 2022 09:35:42 GMT | 5 months ago||Irvine, CA 92630||Prepare regulatory reviews of product formulations. Bachelor’s degree in Chemistry or related regulatory coursework. Author GHS compliant safety data sheets.|
|Manager, Regulatory Affairs||coty||Tue, 10 May 2022 19:48:20 GMT | 30+ days ago||Morris Plains, NJ 07950||Lead the FDA OTC regulatory activities, including compliance and artwork review. Coordinate and advise on regulatory activities in the US that impact to the…|
|Regulatory Affairs Manager - Vaccines & Immune Therapies||AstraZeneca||Mon, 09 May 2022 18:24:54 GMT | 30+ days ago||Gaithersburg, MD 20878||Managed regulatory deliverables across projects/products. The RAM is a contributor to regulatory submission strategy, identifying submission risks and…|
|Regulatory Affairs Manager||McGuff Family of Companies||Fri, 01 Jul 2022 22:40:42 GMT | 2 days ago||Santa Ana, CA 92704||Preparation and submission of regulatory applications, as well as internal regulatory file documentation. Manage regulatory affairs for McGuff Pharmaceuticals,…|
|Associate Director, Regulatory Affairs _ Remote||IQVIA||Wed, 11 May 2022 12:23:45 GMT | 30+ days ago||Remote||Possesses a specific regulatory or technical expertise; Responsible for the development of regulatory business, in accordance with Regulatory Affairs business…|
|Senior Specialist, Regulatory Affairs||PharmaLex||Mon, 21 Mar 2022 23:49:35 GMT | 30+ days ago||Remote||Represents client regulatory affairs team as needed. Supports key regulatory affairs consultants, by providing expertise and innovative solutions to clients and…|
|Associate Manager Regulatory Affairs||Johnson & Johnson||Wed, 08 Jun 2022 20:06:48 GMT | 25 days ago||Skillman, NJ 08558||The Associate Manager, Regulatory Affairs will have regulatory responsibility for the Cough/Cold franchise, which includes marketed products, and products in…|
|Senior Regulatory Affairs Specialist - (remote)||Medtronic||Tue, 26 Apr 2022 22:36:42 GMT | 30+ days ago||Santa Rosa, CA 95403||Review significant regulatory issues with management, as necessary, and negotiate submission issues with regulatory agencies.|
|Senior Manager, Regulatory Affairs||Hamlyn Williams||Thu, 30 Jun 2022 00:13:51 GMT | 4 days ago||New York, NY||Ensure regulatory submissions are maintained in compliance with regulatory requirements. Prepare and maintain regulatory archive.|
|Regulatory Affairs Manager||Global Channel Management,Inc||Wed, 20 Jan 2021 16:51:23 GMT | 17 months ago||Madison, NJ 07940||Pertinent Federal and State laws related to pharmaceutical regulatory affairs. Interacts with various departments as needed on regulatory issues and/or strategy…|
|Regulatory Affairs Consultant||Underwriters Laboratories Inc.||Thu, 31 Mar 2022 04:06:58 GMT | 30+ days ago||Austin, TX 78746||The Quality and Regulatory Affairs Consultant will work within Emergo’s regulatory affairs team and support Emergo’s global consulting services, providing…|
|Regulatory Affairs Manager Brands CMC (Phase 1 to NDA)||Pfizer||Wed, 04 May 2022 20:24:51 GMT | 30+ days ago||Groton, CT||A regulatory CMC professional or an individual with regulatory expertise in pharmaceutical science development or manufacturing and/or specific regulatory…|
|Senior Regulatory Affairs Specialist/Manager||ALPCO||Tue, 18 Jan 2022 09:13:02 GMT | 5 months ago||Salem, NH 03079||Provide the regulatory reviews of customer complaints and define the regulatory reportability. The Senior Regulatory Affairs Specialist/Manager provides…|
|Global Regulatory Affairs Specialist||Forge Biologics||Thu, 23 Jun 2022 18:58:03 GMT | 10 days ago||Columbus, OH||Develop and maintain current regulatory knowledge, including eCTD specifications for successful global regulatory submissions.|
|Director, Regulatory Affairs CMC||Gilead Sciences||Mon, 20 Jun 2022 17:39:38 GMT | 13 days ago||Oceanside, CA||Maintain current working knowledge of regional and global regulatory requirements, analyze current trends and anticipate changes in the regulatory requirements…|
|Regulatory Affairs Associate/Specialist||Vero Biotech LLC||Wed, 02 Feb 2022 00:19:29 GMT | 5 months ago||United States||The RA Associate/Specialist will support day to day regulatory operations including providing regulatory advice and support to assigned project teams, assessing…|
|Regulatory Affairs Associate I||Stefanini||Tue, 14 Jun 2022 13:13:03 GMT | 19 days ago||Glenview, IL||Review label graphics for regulatory compliance and technical accuracy in conjunction with the local Regulatory teams and consultants.|
|Legislative and Regulatory Affairs Manager||Baker Commodities, Inc.||Sat, 11 Jun 2022 09:21:01 GMT | 22 days ago||Vernon, CA 90058||Ensure compliance with priority legislative/regulatory issues and make recommendations for needed changes to Baker management.|
|Regulatory Affairs Associate||CFT Consulting||Fri, 01 Jul 2022 13:49:58 GMT | 2 days ago||Columbus, OH 43085||Manager regulatory submissions to ensure timely regulatory approval of medical devices. Ensure all client product and procedures comply with applicable…|
|Senior Regulatory Affairs Specialist - Remote||Terumo Medical Corporation||Mon, 09 Aug 2021 18:31:16 GMT | 10 months ago||Remote||Provide general regulatory consultation during absence of other associates and/or manager. Demonstrated ability to prepare regulatory submissions independently.|
|Regulatory Affairs Specialist||Covantec||Tue, 26 Apr 2022 22:45:10 GMT | 30+ days ago||Lexington, MA||This person will also provide global regulatory support to already launched products to ensure continued regulatory compliance. Master's degree is advantageous.|
|Regulatory Affairs Manager||McKesson||Wed, 29 Jun 2022 05:02:19 GMT | 4 days ago||Remote||Engage with account managers and customers, as well as internal team personnel as needed to support CSMP process. Ability to collaborate with various teams.|
|Lead Specialist Regulatory Affairs - Remote||CONMED||Wed, 04 May 2022 22:24:46 GMT | 30+ days ago||Denver, CO 80111||Directly interact with regulatory agencies on defined matters. Minimum of 5 years’ related experience in a regulatory, quality or similar position.|
|Regulatory Specialist||Advanced Vascular Dynamics||Sun, 05 Jun 2022 19:17:57 GMT | 28 days ago||Milwaukie, OR 97222||At least four years of experience in regulatory affairs or quality management systems relating to medical devices or formal qualification in a relevant…|
|Regulatory Affairs Senior Manager CMC||Pfizer||Tue, 28 Jun 2022 15:53:15 GMT | 5 days ago||Groton, CT||Experience in regulatory Chemistry Manufacturing and Control (CMC) or with regulatory expertise in pharmaceutical science development or manufacturing and/or…|
|Senior Regulatory Affairs Manager||Saluda Medical||Thu, 23 Jun 2022 19:39:40 GMT | 10 days ago||Bloomington, MN||8+ years experience regulatory affairs experience within the medical device industry (preferably with active implantable devices) including at least 2 years…|
|Regulatory Affairs Specialist||Stradis Healthcare||Tue, 31 May 2022 14:08:47 GMT | 30+ days ago||Waukegan, IL 60085||Works in the regulatory affairs department on assigned projects. Serves as a representative for the regulatory affairs department at process review meetings.|
|Regulatory Affairs Specialist I||Verdesian Life Sciences||Fri, 22 Apr 2022 19:07:41 GMT | 30+ days ago||Cary, NC 27513||BA or BS degree in agriculture, biology, chemistry, animal husbandry/nutrition or related scientific discipline and/or a minimum of 1 year related experience in…|
|Manager, Regulatory Affairs, L'Oreal Research & Innovation||L'Oreal||Fri, 24 Jun 2022 22:17:23 GMT | 9 days ago||Clark, NJ||Relevant regulatory affairs expertise in the cosmetic, OTC, and/or consumer/personal health care industries, with global vision of the profession.|
|Regulatory Affairs Associate- Publishing||Tellus Solutions||Tue, 31 May 2022 18:28:03 GMT | 30+ days ago||Remote||With manager support, manages/provides operational oversight to ensure timely, high quality regulatory submissions. Regulatory associate: 5 years (Preferred).|
|Specialist, Regulatory Affairs||Emergent Biosolutions||Thu, 30 Jun 2022 18:59:01 GMT | 3 days ago||Gaithersburg, MD 20879||Interact with internal regulatory staff and external vendors to facilitate on-time publishing and submission of regulatory documents.|
|Senior Associate, Regulatory Affairs Submisson Management||ABBVIE||Fri, 17 Jun 2022 13:28:12 GMT | 16 days ago||Madison, NJ||Serves as primary interface with the Area and Affiliate regulatory team to coordinate/complete international regulatory documents and product sample requests in…|
|Manager, Regulatory Affairs - Aesthetics||ABBVIE||Thu, 16 Jun 2022 15:53:29 GMT | 17 days ago||Irvine, CA||Maintains professional relationships within the regulatory groups and with functional areas outside regulatory. Supports health authority audits/inspections.|
|Regulatory Affairs Associate||Medicago||Sat, 28 May 2022 00:05:40 GMT | 30+ days ago||Durham, NC 27713||3-6 years experience in pharmaceutical or biotech regulatory affairs operations. Plan and track regulatory submissions.|
|Regulatory Affairs (Senior) Manager||I Mab Biopharma||Wed, 18 May 2022 18:28:50 GMT | 30+ days ago||Remote||This position will manage multiple immunology/oncology projects by providing support for the delivery of high-quality regulatory submissions, including managing…|
|Regulatory Affairs Consultant / Senior Consultant - Labeling||Precision Life Sciences||Wed, 29 Jun 2022 15:04:19 GMT | 4 days ago||Remote||Communicate potential new business lead to PC management and account managers. Prepare and review materials for recurring meetings pertaining to CCDS updates,…|
|Regulatory Affairs Project Coordinator||Abbott Laboratories||Fri, 27 May 2022 21:31:26 GMT | 30+ days ago||Lake Forest, IL||Supports project teams to obtain worldwide regulatory approval or clearance for division products. The position of Regulatory Affairs Project Coordinator is…|
|Manager, Global Regulatory Affairs||PTC THERAPEUTICS||Mon, 06 Jun 2022 21:57:06 GMT | 27 days ago||Remote||Support global regulatory leads (GRLs) in developing global regulatory strategy for drugs and gene therapies in development through conducting research,…|
|Manager, Regulatory Affairs||American Society of Gene & Cell Therapy||Fri, 01 Jul 2022 17:01:12 GMT | 2 days ago||Remote||Work collaboratively to draft regulatory policy comments to other governmental bodies as needed. Communicate and provide summaries and talking points for…|
|Regulatory Affairs Coordinator, Lead||MemorialCare Health Services||Fri, 01 Jul 2022 01:25:28 GMT | 3 days ago||Long Beach, CA||Lead regulatory activities for multiple clinical research projects. Perform high quality clinical review of regulatory forms and associated documentation.|
|Senior Regulatory Affairs Associate, Clinical Safety and Labelling Management||Pfizer||Tue, 28 Jun 2022 15:54:36 GMT | 5 days ago||Lake Forest, IL||Reviews regulatory submissions, regulatory commitments, strategy decisions, and changes to resource allocations with manager prior to execution.|
|Regulatory Specialist||Transonic Systems Inc||Wed, 01 Jun 2022 20:14:47 GMT | 30+ days ago||Ithaca, NY 14850||Assist in the creation of regulatory documentation in conjunction with the Engineering team that can be used to support FDA, EU and other worldwide regulatory…|
|DK - Regulatory Affairs Manager||Y-mAbs Therapeutics||Tue, 14 Jun 2022 19:22:22 GMT | 19 days ago||New York, NY||You preferably have 1-2 years’ regulatory experience, maybe through student. Y-mAbs Therapeutics A/S (Y-mAbs) is now.|
|Senior Regulatory Affairs Specialist (Remote / Flexible)||Insulet Corporation||Thu, 09 Jun 2022 19:48:46 GMT | 24 days ago||United States||Provide assistance in planning, creating, organizing and interpreting regulatory documents for submission to various regulatory agencies.|
|Associate, Global Regulatory Affairs||Pfizer||Tue, 28 Jun 2022 15:50:19 GMT | 5 days ago||Lake Forest, IL||Assembles and prepares regulatory submissions and other regulatory documents to regulatory agencies. Assists manager in preparation of regulatory strategies and…|
|Regulatory Affairs, Study Start Up Specialist||CTI Clinical Trial Services, Inc||Fri, 17 Jun 2022 22:24:26 GMT | 16 days ago||Remote||Job Purpose / Summary: Manage essential Regulatory documentation for multiple studies or projects. Interact with study teams, site personnel, sponsors, and CTI…|
|Regulatory Affairs Manager - International||Abbott Laboratories||Mon, 20 Jun 2022 17:32:42 GMT | 13 days ago||Abbott Park, IL||Review validation reports for regulatory submission soundness. Keep informed of global regulatory information; prepare impact assessments.|
|Regulatory Affairs Specialist||Paula's Choice Skincare||Thu, 19 May 2022 01:21:06 GMT | 30+ days ago||Seattle, WA||This key role will act as an advanced technical and knowledge contributor, as well as a project manager who will help facilitate all regulatory activities in…|
|Senior Regulatory Affairs Specialist||Aim Biopharma Solutions, LLC||Thu, 07 Apr 2022 21:07:52 GMT | 30+ days ago||Remote||Regulatory Affairs Project manager with experience in BLA filings and Supplements. Bachelor’s degree preferred with 4+ years of regulatory and manufacturing…|
|Regulatory Affairs Customer Specialist||BASF Corporation||Fri, 01 Jul 2022 07:55:18 GMT | 2 days ago||Florham Park, NJ 07932||In this role you will provide regulatory affairs support to customers, marketing, R&D, technical service, sales, and quality management and work cooperatively…|
|Regulatory Affairs Specialist (Mid) - Regulatory Aff||Bayer||Fri, 01 Jul 2022 14:53:01 GMT | 2 days ago||Chesterfield, MO 63017||Bachelor's degree with 4 years of relevant regulatory affairs experience. Master's degree with 2 years of relevant regulatory affairs experience.|
|Scientist, Regulatory Affairs, L'Oreal Research & Innovation||L'Oreal||Tue, 24 May 2022 16:26:21 GMT | 30+ days ago||Clark, NJ||To perform regulatory assessments and working with international team on regulatory compliance collaborations. Reports To: Manager, Regulatory Compliance.|
|Regulatory Affairs Associate - Telecommute||Optum||Fri, 03 Jun 2022 18:05:18 GMT | 30 days ago||Eden Prairie, MN 55346||1+ years of regulatory filings experience and/or past experience with CMS or a State Medicaid agency. You will assist in resolving licensing issues as needed…|
|Manager, Regulatory Affairs||BlueSphere Bio||Thu, 30 Jun 2022 15:09:06 GMT | 3 days ago||Remote||Manage external regulatory and cross-functional vendors and consultants to ensure successful regulatory submissions. Experience in cell therapy preferred.|
|Regulatory Affairs Specialist||Medtronic||Thu, 12 May 2022 16:38:10 GMT | 30+ days ago||Minnesota||Minimum of 2 years of experience in regulatory affairs in the medical device industry. Work with engineers and technical experts to resolve potential regulatory…|
|Regulatory Affairs Specialist||IGM Resins||Wed, 29 Jun 2022 12:42:52 GMT | 4 days ago||Remote||Responsible for regulatory info gathering (NPI etc) and registration of products ( with manager / consultants when required) on global inventories as per…|
|Program Manager for Research Compliance and Regulatory Affairs/Pauley Heart Center||Virginia Commonwealth University||Tue, 21 Jun 2022 13:15:18 GMT | 12 days ago||Richmond, VA 23284||Acts as program manager for research compliance and regulatory affairs within the Pauley Heart Center and the Division of Cardiology.|
|Technical Writer, Regulatory Affairs||GE Power Portfolio||Tue, 24 May 2022 22:39:48 GMT | 30+ days ago||Wilmington, NC 28402||Typically reports to a manager or head of the Regulatory Affairs organization. Familiarity with US NRC regulatory requirements and guidance, including NUREG…|
|Regulatory Affairs Administrative Coordinator (Remote Eligible)||University of Pennsylvania||Sat, 02 Jul 2022 10:00:01 GMT | 1 day ago||Philadelphia, PA 19104||Responsibilities include acting as the primary on-site liaison with external entities including pharmaceutical companies, contract research organizations (CROs)…|
|Regulatory Affairs Specialist (Remote)||BD||Fri, 10 Jun 2022 13:12:46 GMT | 23 days ago||San Jose, CA||This includes executing on tasks and deliverables to regulatory project timelines and maintaining regulatory information to ensure that all regulatory…|
|Regulatory Affairs Specialist||Nihon Kohden America, Inc||Fri, 01 Jul 2022 20:11:05 GMT | 2 days ago||Irvine, CA 92618||2+ years of experience in regulatory affairs. Work with RA Leadership and other members of the RA team to set strategy for regulatory approval to introduce new…|
|Senior Program Manager-Regulatory Affairs||Philips||Wed, 06 Apr 2022 15:50:01 GMT | 30+ days ago||Remote||Experience in regulatory affairs, or interacting with health authorities is highly preferred. Assist in the development of multi-country regulatory strategy and…|
|Regulatory Affairs Specialist – Software Medical Device||ICON Clinical Research, Inc.||Thu, 07 Apr 2022 20:29:12 GMT | 30+ days ago||Remote||Develop/maintain appropriate regulatory strategy, regulatory processes, and product regulatory plan for ICON’s Care Innovations’ medical device products and…|
|Manager Regulatory Affairs||Seagen||Sat, 11 Jun 2022 00:17:50 GMT | 23 days ago||Bothell, WA 98021||Experience in the preparation/submission of regulatory documentation to support regulatory submissions. Communicate regulatory policy to development teams and…|
|Regulatory Affairs Assoc. III - Advertising, Promotion & Labeling (Remote)||Tolmar Inc.||Mon, 13 Jun 2022 21:25:12 GMT | 20 days ago||Windsor, CO 80550||Serve as regulatory representative on project teams and offer regulatory opinions with consultation from senior regulatory management.|
|Regulatory Affairs Specialist, NA, Beauty + Home and Food + Beverage||Aptar||Fri, 01 Jul 2022 12:17:08 GMT | 2 days ago||Remote||Minimum 3 years of experience in regulatory affairs, including internship or apprenticeship, highly appreciated. Attract and develop high performing people.|
|Premarket Regulatory Affairs Manager||Applied Medical||Sat, 02 Jul 2022 10:47:25 GMT | 1 day ago||Rancho Santa Margarita, CA 92688||Manage regulatory submissions and communicate with regulatory authorities. Minimum 3 years of experience in regulatory affairs or quality assurance in the…|
|Regulatory Affairs Specialist||LeMaitre||Thu, 16 Jun 2022 02:45:28 GMT | 18 days ago||Burlington, MA 01803||At least one year regulatory experience in industry (including internship). Ability to effectively present information and respond to questions from groups of…|
|Regulatory Affairs & Clinical Study Coordinator||Endosoft LLC||Tue, 28 Jun 2022 13:21:24 GMT | 5 days ago||Remote||Administers research programs and the day-to-day non-medical operations, including managing regulatory affairs program and study protocol development, quality…|