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11-9199.01 - Regulatory Affairs Managers


Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.


Key Facts
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Bright Outlook
1
Career Details
Green Job
Career Details
Current Employment
985,600
Estimate
Forecasted Employment
1,023,600
Estimate
Change in Employment
+38,000
Estimate
Change in Employment %
+3.9%
Estimate
Tasks
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Tasks
The tasks listed below can be performed to prepare you for a career in this field.
Core
  • 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.
Supplemental
  • 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.
All data sourced from US Department of Labor, Employment & Training Administration O*Net Database.
Knowledge
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Knowledge

The items listed below are organized into sections that contain knowledge useful for pursuing a career in this field. Each section also contains a "Percentage of Importance" statistic that shows how relevant an item is to the occupation.
 English Language
  • 84%
    Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.
 Law and Government
  • 81%
    Knowledge of laws, legal codes, court procedures, precedents, government regulations, executive orders, agency rules, and the democratic political process.
 Administration and Management
  • 73%
    Knowledge of business and management principles involved in strategic planning, resource allocation, human resources modeling, leadership technique, production methods, and coordination of people and resources.
 Biology
  • 65%
    Knowledge of plant and animal organisms, their tissues, cells, functions, interdependencies, and interactions with each other and the environment.
 Medicine and Dentistry
  • 64%
    Knowledge of the information and techniques needed to diagnose and treat human injuries, diseases, and deformities. This includes symptoms, treatment alternatives, drug properties and interactions, and preventive health-care measures.
 Education and Training
  • 63%
    Knowledge of principles and methods for curriculum and training design, teaching and instruction for individuals and groups, and the measurement of training effects.
 Clerical
  • 60%
    Knowledge of administrative and clerical procedures and systems such as word processing, managing files and records, stenography and transcription, designing forms, and other office procedures and terminology.
 Computers and Electronics
  • 60%
    Knowledge of circuit boards, processors, chips, electronic equipment, and computer hardware and software, including applications and programming.
 Production and Processing
  • 59%
    Knowledge of raw materials, production processes, quality control, costs, and other techniques for maximizing the effective manufacture and distribution of goods.
 Mathematics
  • 58%
    Knowledge of arithmetic, algebra, geometry, calculus, statistics, and their applications.
 Chemistry
  • 58%
    Knowledge of the chemical composition, structure, and properties of substances and of the chemical processes and transformations that they undergo. This includes uses of chemicals and their interactions, danger signs, production techniques, and disposal methods.
 Engineering and Technology
  • 53%
    Knowledge of the practical application of engineering science and technology. This includes applying principles, techniques, procedures, and equipment to the design and production of various goods and services.
 Personnel and Human Resources
  • 52%
    Knowledge of principles and procedures for personnel recruitment, selection, training, compensation and benefits, labor relations and negotiation, and personnel information systems.
 Design
  • 51%
    Knowledge of design techniques, tools, and principles involved in production of precision technical plans, blueprints, drawings, and models.
All data sourced from US Department of Labor, Employment & Training Administration O*Net Database.
Tools
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Tools
The tools listed below include machines, equipment, tools, and software that is useful for individuals who are interested in this career.
 Personal communication devices
  • Multi-line telephone systems
 Computers
  • Laptop computers
  • Desktop computers
  • Personal computers
 Computer printers
  • Computer laser printers
 Duplicating machines
  • Photocopying equipment
  • Laser facsimile machines
All data sourced from US Department of Labor, Employment & Training Administration O*Net Database.
Technology
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Technology
The technologies listed below include machines, equipment, tools, and software that is useful for individuals who are interested in this career.
 Business function specific software
  • Microsoft ProjectHOT
  • Microsoft SharePointHOT
  • Total quality management TQM software
  • Microsoft OfficeHOT
 Content authoring and editing software
  • Microsoft VisioHOT
  • Microsoft WordHOT
  • Word processing software
  • Microsoft PowerPointHOT
  • Microsoft ExcelHOT
  • Spreadsheet software
  • Document publishing software
 Content management software
  • Adlib Express
  • Adobe Systems Adobe AcrobatHOT
  • Axway eSubmissions
  • Datafarm S-Cubed
  • Datafarm a-Pulse
  • Datafarm eCTDGatekeeper
  • Datafarm eCTDViewer
  • DoubleBridge ROSETTA Phoenix eCTD Viewer
  • DoubleBridge ROSETTA Pyramid
  • DoubleBridge ROSETTA Sceptre
  • DoubleBridge ROSETTA Scribe
  • Electronic common technical document eCTD software
  • Electronic common technical document eCTD validating software
  • Electronic common technical document eCTD viewing software
  • Electronic document management system EDMS
  • Enterprise content management ECM software
  • Extedo DOCvalidator
  • Extedo PLmanager
  • Extedo eCTDmanager Suite
  • GlobalSubmit REVIEW
  • GlobalSubmit VALIDATE
  • Image Solutions ISIPublisher
  • Image Solutions eCTDXpress
  • Lorenz DocuBridge
  • Lorenz eValidator
  • Lorenz labelBridge
  • MedXView eCTDauditor
  • Octagon StartingPoint
  • Octagon ViewPoint eCTD Complete
  • Take Solutions PharmaReady Document Management System
  • Thomson Reuters Liquent CoreDossier Submission Accelerator for eCTD
  • Virtify eCTD
 Data management and query software
  • Database software
  • Microsoft AccessHOT
  • Structured query language SQLHOT
  • Dialog DialogLink
  • TableauHOT
 Development software
  • Integrated development environment IDE softwareHOT
  • Software development tools
  • XML authoring software
 Industry specific software
  • Analyse-it
  • Risk management software
  • Statistical analysis software
  • Aris Global Register
  • MasterControl software
  • MediRegs E-dition Compliance Monitor
  • MediRegs Pharmaceutical Regulation Suite
  • MediRegs Regulation and Reimbursement Suite
  • MediRegs Risk Assessment Manager
  • Pilgrim Regulatory Submission
  • SAP EHS Management
  • Samarind RMS
  • Thomson Reuters Liquent InSight Suite
 Information exchange software
  • IBM NotesHOT
  • Microsoft OutlookHOT
All data sourced from US Department of Labor, Employment & Training Administration O*Net Database.
Certifications
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Certifications
The certifications listed below are useful to pursue if you are interested in a career in this field.
 Advanced
 Unknown
 Core
All data sourced from US Department of Labor, Employment & Training Administration O*Net Database.
Licensing
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Licensing
The licensing information below is organized into sections and is useful for pursuing if you are interested in a career in this field.
No specific licensing information is listed for this occupation in the area you have selected.
All data sourced from US Department of Labor, Employment & Training Administration O*Net Database.
Related Programs
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Programs related to this career, offered by participating institution(s), are listed below.

Clicking on the Degree programs in the list below will take you away from the Careers page.
INSTITUTION
PROGRAMS
Blue Ridge Community College
Brightpoint Community College
Central Virginia Community College
Danville Community College
Eastern Shore Community College
Germanna Community College
J Sargeant Reynolds Community College
Laurel Ridge Community College
Mountain Empire Community College
Mountain Gateway Community College
New River Community College
Northern Virginia Community College
Patrick & Henry Community College
Paul D. Camp Community College
Piedmont Virginia Community College
Rappahannock Community College
Southside Virginia Community College
Southwest Virginia Community College
Tidewater Community College
Virginia Highlands Community College
Virginia Peninsula Community College
Virginia Western Community College
Wytheville Community College
Jobs
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Job List

The jobs listed below have been found near USA (entered above) and are related to the Career selected. You can use the Location box above to change the city/state or zipcode to explore this or other careers at other locations of interest.


Clicking on a Job in the list below will take you away from the Careers page.
Job Title Company Date Location Details
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…
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