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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
(Remote) Regulatory Specialist II Global Edgewell Personal Care Brands Wed, 07 Sep 2022 01:09:01 GMT | 30+ days ago Ormond Beach, FL 32174 Prepare regulatory submissions to health authorities. Provide day-to-day regulatory support for new product development and commercialization projects.
Senior Analyst, Regulatory Affairs Adtalem Global Education Tue, 06 Dec 2022 01:42:17 GMT | 1 day ago Remote Unresolved items to manager as needed. Delegate to the manager in their absence. Represents Regulatory Affairs in institution meetings; provide regulatory…
Manager, Regulatory Affairs Glanbia Foods Fri, 18 Nov 2022 19:35:56 GMT | 18 days ago Grove, IL 5 years or more experience in Food Industry in regulatory role required. Create and/or update document standard operating procedures for nutrition databases,…
Regulatory Affairs Technologist Metropolitan Market Thu, 29 Sep 2022 14:30:02 GMT | 30+ days ago Bellevue, WA Must be able to communicate cross functionally between directors, managers, technical staff and vendor community daily.
Senior Regulatory Affairs Specialist XGen Pharmaceuticals DJB Fri, 02 Dec 2022 09:07:28 GMT | 4 days ago Horseheads, NY 14845 Provide knowledge-based input and assist in formulation of regulatory strategy and tactics for regulatory submissions.
Regulatory Affairs Specialist Cue Health Wed, 12 Jan 2022 18:36:11 GMT | 10 months ago California Assist in providing regulatory affairs related training to employees. The RAS will be responsible to prepare regulatory affairs relevant Standard Operating…
Senior Regulatory Affairs Specialist Medtronic Tue, 11 Oct 2022 22:34:34 GMT | 30+ days ago Santa Rosa, CA 95403 Bachelor’s degree with 4 years of experience in regulatory affairs or the medical device industry,. Or an advanced degree with 2 years of experience in…
Regulatory Affairs Associate II(Submissions) Tellus Solutions Wed, 17 Aug 2022 03:00:58 GMT | 30+ days ago North Chicago, IL With manager support, manages/provides operational oversight to ensure timely, high quality regulatory submissions. Plans and conducts submission team meetings.
Global Director of Clinical & Regulatory Affairs Helen of Troy Tue, 06 Dec 2022 00:11:53 GMT | 1 day ago Marlborough, MA 01752 Work closely with US, Europe, and Asia regulatory affairs managers to provide and acquire the required documentation for product registrations.
Regulatory & Medical Affairs - Project Manager ASK Consulting Fri, 18 Nov 2022 19:57:03 GMT | 18 days ago Summit, NJ Support internal audit and regulatory inspection activity as needed. Organize and appropriately document (within internal databases) the formal internal review…
Regulatory Affairs Coordinator Phibro Animal Health Corporation Mon, 17 Oct 2022 16:27:25 GMT | 30+ days ago Quincy, IL 62305 Develop and implement regulatory strategies for assigned projects. Represent regulatory on internal cross functional teams and with external regulatory agencies…
Director of Rates and Regulatory Affairs Tue, 29 Nov 2022 04:27:23 GMT | 7 days ago Uniondale, NY Developing LIPA’s short-term and long-term rate policy and regulatory strategy, which includes proposing improvements and refinements to LIPA’s rate policies…
Manager, Regulatory Affairs Thermo Fisher Scientific Thu, 01 Dec 2022 10:05:30 GMT | 5 days ago Virginia Lead interactions with global regulatory authorities and partners to gain alignment on regulatory strategies and resolve concerns to expedite approval of…
Manager, Regulatory Affairs Nektar Therapeutics Thu, 24 Nov 2022 01:57:48 GMT | 13 days ago San Francisco, CA 94158 They will be primarily responsible for preparing and reviewing regulatory dossiers prior to review by senior regulatory management.
Government & Regulatory Affairs Manager Houston Methodist Mon, 10 Oct 2022 21:13:18 GMT | 30+ days ago Houston, TX 77054 Serves as a resource for regulatory information and guidance. Assists management with strategic planning for known and potential regulatory activities related…
Regulatory Affairs Assistant Saint Louis University Sat, 03 Dec 2022 00:59:40 GMT | 4 days ago St. Louis, MO 63110 Initiates and completes special projects such as long term storage of regulatory files, developing better communication and filing systems for the regulatory…
Regulatory Affairs Specialist Hollister Incorporated Tue, 11 Oct 2022 20:18:57 GMT | 30+ days ago Libertyville, IL 60048 Compile and submit, in a timely and accurate manner, regulatory documents according to regulatory requirements. Provide regulatory advice to project teams.
Regulatory Affairs, Specialist Suterra Thu, 24 Nov 2022 05:24:07 GMT | 12 days ago Portland, OR This person will work with international cross-functional teams, build relationships with customers and regulatory agencies, and coordinate regulatory studies.
Associate, Regulatory Affairs - Drug Enforcement Administration (DEA) Dr. Reddy's Laboratories, Inc. Sat, 12 Nov 2022 08:18:11 GMT | 24 days ago Princeton, NJ 08540 Ensure appropriate maintenance of regulatory document files. Assist SHV manager for DEA audit at the facility. Support for CBN NOC applications as needed.
Post Doctoral Fellow - Regulatory Affairs - Labeling Boehringer Ingelheim Fri, 02 Sep 2022 01:33:19 GMT | 30+ days ago Connecticut Review regulatory developments with RA Product Labeling Groups and keep BI abreast of changes in the US regulatory environment impacting product labeling.
Senior Regulatory Affairs Manager FUJIFILM Irvine Scientific Thu, 01 Dec 2022 16:03:24 GMT | 5 days ago Santa Ana, CA 92705 Writing and/or revising regulatory related standard operating procedures. Ability to interpret regulatory standards, guidance’s and laws.
Regulatory Affairs Specialist 3SYNC Research Thu, 17 Nov 2022 23:29:30 GMT | 19 days ago Fort Lauderdale, FL 33309 Supports initial regulatory submission documents for IRB and sponsors to ensure site meets regulatory readiness metrics with a focus on expedited study start up…
Manager, Life Sciences, Regulatory Affairs KPMG Sat, 15 Oct 2022 12:17:45 GMT | 30+ days ago Boston, MA 02111 Structure and perform analysis on regulatory-related processes, data, business requirements, operating models, IT systems.
Sr. Manager, Regulatory Affairs Strategy Consortium Solutions Wed, 10 Aug 2022 23:48:24 GMT | 30+ days ago Remote Provide regulatory interpretation of regulations and guidance. Prepare responses as requested by regulatory agencies. FDA regulations: 1 year (Preferred).
Manager, Regulatory Affairs CMC Gilead Sciences Fri, 11 Nov 2022 17:36:35 GMT | 25 days ago Foster City, CA Under the general direction of a senior Regulatory Affairs CMC professional supports the development of global regulatory strategies, provides regulatory…
Americas Regulatory Affairs Specialist ICL Group Mon, 31 Oct 2022 15:09:48 GMT | 30+ days ago St. Louis, MO 63141 Maintains product regulatory data in SAP substance database. Performs regulatory compliance assessments for raw materials, finished products and imports.
Regulatory Affairs Associate/Specialist Vero Biotech Inc Wed, 02 Feb 2022 00:19:29 GMT | 10 months ago Atlanta, GA The RA Associate/Specialist will support day to day regulatory operations including providing regulatory advice and support to assigned project teams, assessing…
Regulatory Affairs Lead, Publishing & Submissions Krystal Biotech Fri, 11 Nov 2022 23:28:15 GMT | 25 days ago Remote Lead regulatory submission publishing – including editing, formatting, tracking, compiling regulatory submissions. Manage relationships with business partners.
Regulatory Affairs Associate Rangam Consultants Inc. Wed, 09 Nov 2022 21:09:20 GMT | 27 days ago Remote Typically reports to a manager or head of a unit/department. Proven successful track record of authoring/submission/approval of APAC regulatory submission …
Regulatory Affairs Director Saluda Medical Wed, 02 Nov 2022 09:18:57 GMT | 30+ days ago San Francisco, CA 94016 10+ years experience regulatory affairs experience within the medical device industry (preferably with active implantable devices) including at least 4 years…
Global Regulatory Affairs Manager - CTA submissions (Fully Remote) Freyr Solutions Mon, 10 Oct 2022 17:38:41 GMT | 30+ days ago Remote Regulatory operations: 3 years (Preferred). _Provide critical support in developing global regulatory strategy, planning and execution of global investigational…
Director, Regulatory Affairs Liaison - Oncology Merck Wed, 16 Nov 2022 20:03:44 GMT | 20 days ago Rahway, NJ M.S. with minimum of 10 years drug development or clinical experience or regulatory affairs. Develops worldwide product regulatory strategy to optimize label…
Regulatory Affairs Specialist Colorcon Fri, 04 Nov 2022 03:03:34 GMT | 30+ days ago West Point, PA 19454 Communicate directly with customers regarding quality and regulatory requests. Participate in projects requiring quality or regulatory representation as…
Associate Director, Regulatory Affairs Liaison- Oncology Merck Fri, 02 Dec 2022 02:06:24 GMT | 5 days ago North Wales, PA Assist the global regulatory lead in authoring of regulatory strategy documents. Prior regulatory experience interacting with a major regulatory agency is…
Regulatory Affairs Manager Karyopharm Therapeutics Inc. Thu, 20 Oct 2022 01:43:39 GMT | 30+ days ago Remote Good understanding of relevant regulatory guidance documents that pertain to drug development and commercialization. Careful attention to detail and accuracy.
Regulatory Affairs Manager REMOTE Premier Brands of America, Inc. Thu, 29 Sep 2022 13:31:10 GMT | 30+ days ago Remote Interact with state and national regulatory agencies on a regular basis. Keep up to date on regulatory policy and procedural changes that could affect the…
Senior Manager Regulatory Affairs Johnson & Johnson Fri, 02 Dec 2022 02:12:25 GMT | 5 days ago Cincinnati, OH Manage instruments and accessories regulatory team. Perform regulatory research to inform strategy. Strong independent regulatory submissions development…
Manager Regulatory Affairs Teva Pharmaceuticals Tue, 18 Oct 2022 22:05:15 GMT | 30+ days ago Salt Lake City, UT Pertinent Federal and State laws related to pharmaceutical regulatory affairs. Regulatory issues and helps prevent unnecessary regulatory delays.
Regulatory Intelligence Project Manager Freyr Solutions Mon, 28 Nov 2022 15:53:46 GMT | 8 days ago Remote Regulatory Intelligence Project Manager* with *Regulatory Intelligence* Experience. Define and execute project strategies in alignment with portfolio goals and…
Regulatory Affairs Manager Elliquence Sat, 15 Oct 2022 23:39:29 GMT | 30+ days ago Boca Raton, FL 33431 Engineering, life sciences, regulatory affairs degree preferred. Medical device regulatory affairs experience required, with thorough understanding of FDA and…
Senior Director, Regulatory Affairs Team Leader for Immunoscience and Fibrosis (I&F) Bristol Myers Squibb Mon, 05 Dec 2022 21:56:37 GMT | 1 day ago Princeton, NJ Works with the regulatory product managers (submissions) and regulatory operations group, for preparation, production and submission of health authority…
Director of Regulatory Affairs & Quality Everly Health Thu, 29 Sep 2022 23:38:51 GMT | 30+ days ago Remote Experienced with coordination and direct submission activities for a variety of regulatory approvals including PMAs. Support FDA, NYDOH, and HHS audits.
Global Regulatory Affairs Specialist Mizuho OSI Sat, 19 Nov 2022 22:42:53 GMT | 17 days ago Union City, CA 94587 This position has primary responsibility for assembling regulatory documents for review by the regulatory affairs management.
Manager Regulatory Affairs Operations Ascendis Pharma Mon, 05 Dec 2022 19:37:01 GMT | 1 day ago Palo Alto, CA College degree and at least 4 years of experience performing directly relevant regulatory operations activities in the pharmaceutical and/or biotechnology…
Regulatory Affairs Associate TruMinds Technologies Thu, 08 Sep 2022 01:41:35 GMT | 30+ days ago Frisco, TX Represents regulatory affairs in project team meetings and provides regulatory guidance and perspective to team members in determining appropriate actions in…
Regulatory Affairs Specialist Molnlycke Healthcare Tue, 04 Oct 2022 21:33:59 GMT | 30+ days ago Peachtree Corners, GA 30092 Active team member during product development to provide guidance on regulatory requirements. Serve as strategic regulatory partner to the commercial team both…
Director, Government & Regulatory Affairs Comcast Wed, 30 Nov 2022 22:32:16 GMT | 6 days ago Puyallup, WA 98371 Oversees corporate initiatives and community affairs activities. Oversees government affairs outreach strategies related to corporate initiatives.
Regulatory Affairs Specialist Texas Refinery Corp Mon, 05 Dec 2022 16:52:10 GMT | 1 day ago Mansfield, TX 76063 Ability to raise issues with colleagues and managers in a proactive, professional manner. Identify gaps and mitigate potential plant hazards, prepare for…
Senior Regulatory Affairs Specialist (REMOTE) Implant Direct Thu, 08 Sep 2022 06:21:24 GMT | 30+ days ago New York, NY Direct communication with regulatory authorities regarding company’s regulatory filings. 5Represent Regulatory Affairs on change controls and provide regulatory…
Senior Regulatory Affairs Beckman Coulter Diagnostics Mon, 07 Nov 2022 22:58:20 GMT | 29 days ago Chaska, MN 55318 Also provide pre-market regulatory initiatives for immunoassay devices, ensuring the development and implementation of these advanced and aggressive regulatory…
Manager - Regulatory Affairs CVS Health Sat, 01 Oct 2022 22:09:34 GMT | 30+ days ago Arizona Your regulatory work will also focus on guiding client decision making in the context of regulatory requirements. Processes in order to determine compliance.
CMC Regulatory Affairs Manager Tekskills Inc Mon, 05 Dec 2022 19:24:06 GMT | 1 day ago Remote Proven and relevant regulatory affairs experience in pharmaceutical, vaccine, or biological products; or related fields. FDA regulations: 1 year (Preferred).
Regulatory Affairs Specialist PMT Corporation Tue, 06 Dec 2022 23:44:00 GMT | 4 hours ago Chanhassen, MN Minimum 2 years’ experience in regulatory affairs in health sciences, preferably medical devices. Bachelor’s degree in science, regulatory affairs, engineering,…
Associate, Regulatory Affairs Submission Management ABBVIE Fri, 14 Oct 2022 13:14:07 GMT | 30+ days ago Lake County, IL Reviews project progress with manager on a regular basis with direction provided by manager. This individual is recognized as a very knowledgeable in their…
Associate Regulatory Affairs Specialist (Remote) Henry Schein Thu, 08 Sep 2022 17:10:25 GMT | 30+ days ago Melville, NY Support Distribution Center management and designated staff on the actions necessary to maintain regulatory compliance. Attention to detail and accuracy.
Associate II, Regulatory Affairs - Device (Remote) ICU Medical, Inc. Sat, 20 Aug 2022 00:32:29 GMT | 30+ days ago Plymouth, MN 55442 Follows scientific arguments, identifies regulatory scientific data needs and regulatory issues with alignment of regulatory management.
Manager, Regulatory Affairs Volto Consulting Wed, 30 Nov 2022 18:36:05 GMT | 6 days ago Remote Regulatory affairs in pharmaceutical, vaccine: 6 years (Required). Demonstrate an understanding of regulatory affairs and apply this understanding to the…
Scientist - Regulatory Affairs I Stefanini, Inc Sat, 03 Dec 2022 02:43:00 GMT | 4 days ago Glenview, IL Review label graphics for regulatory compliance and technical accuracy in conjunction with the local Regulatory teams and consultants.
Senior Regulatory Affairs Specialist - (remote) Medtronic Tue, 26 Apr 2022 22:36:42 GMT | 7 months ago Santa Rosa, CA 95403 Or advanced degree with a minimum of 2 years of medical device regulatory affairs or related experience. Bachelor’s degree with a m inimum of 4 years of medical…
Regulatory Affairs Manager Alcon Tue, 15 Nov 2022 23:56:54 GMT | 21 days ago Fort Worth, TX 76116 Provide high quality regulatory support for assigned products/projects with a thorough understanding of the US FDA and EU (MDD/MDR) medical device regulatory…
Specialist, Regulatory Affairs Metagenics Tue, 27 Sep 2022 00:55:57 GMT | 30+ days ago Aliso Viejo, CA 92656 Under the direction of and in conjunction with the Manager, Regulatory Affairs, coordinates and collaborates with marketing brand managers and research and…
Regulatory Affairs Manager Kyowa Kirin International plc Fri, 28 Oct 2022 06:16:32 GMT | 30+ days ago Remote Management of regulatory product information. Life science qualification with broad experience in the pharmaceutical industry, and specifically in EMEA and…
Senior Consultant and Regulatory Affairs Stefanini, Inc Thu, 01 Dec 2022 14:43:37 GMT | 5 days ago Deerfield, IL 60015 Develop and document sound regulatory decisions and justifications. Provide project performance feedback to the team member's supervisor/manager.
Manager, Regulatory Affairs Technical Resources International, Inc. Mon, 22 Aug 2022 17:38:53 GMT | 30+ days ago Bethesda, MD 20817 Perform literature searches, attend meetings, etc. as needed to support regulatory document preparation, regulatory intelligence, and regulatory strategy, and…
Regulatory Affairs Specialist Epimed International Thu, 29 Sep 2022 15:28:13 GMT | 30+ days ago Dallas, TX 75234 Provide regulatory support to any department that requires assistance. Maintains and keeps regulatory standards up to date as needed.
Manager, Regulatory Affairs Imbrium Therapeutics L.P. Wed, 19 Oct 2022 21:04:58 GMT | 30+ days ago Remote Elevation of regulatory issues to regulatory management. Electronic rendering and publishing of regulatory submissions. EEOC Know Your Rights (Spanish).
Manager Regulatory Affairs AmeriHealth Caritas Tue, 29 Nov 2022 21:41:18 GMT | 7 days ago Baton Rouge, LA Five years of professional work experience in a healthcare/managed care regulatory environment preferred. Manages the review and analysis of proposed and final…
Manager Regulatory Affairs Lutheran Medical Center Sat, 30 Jul 2022 10:41:07 GMT | 4 months ago Wheat Ridge, CO 80033 Master’s Degree or at least five (5) years of regulatory experience, preferred. Bachelor’s Degree in a health-related field or at least three (3) years of…
Senior Manager, Regulatory Affairs - remote Oscar Health Thu, 17 Nov 2022 00:29:26 GMT | 20 days ago New York, NY 6+ years' experience in health care compliance, regulatory affairs, government affairs, legal or a similar field.
Manager, Global Regulatory Affairs (GRA) Excellence BeiGene Fri, 02 Dec 2022 19:17:48 GMT | 4 days ago Remote This individual will be responsible for supporting the implementing the several programs globally while fostering collaboration amongst key stakeholders within…
Manager, Regulatory Affairs - Wound Closure and Healing - Ethicon, Inc Johnson & Johnson Tue, 29 Nov 2022 20:07:28 GMT | 7 days ago Raritan, NJ Utilize strategic regulatory thinking along with technical expertise to implement regulatory strategies for product clearances and approvals.
IT Business Partner, R&D and Regulatory Affairs Viatris Wed, 13 Apr 2022 06:33:10 GMT | 7 months ago Remote Coordinating with Lead of Quality Systems for regulatory compliance issues. Ensuring compliance of R&D systems with global and market-specific regulatory…
Staff Regulatory Affairs Beckman Coulter Diagnostics Tue, 25 Oct 2022 22:58:55 GMT | 30+ days ago Chaska, MN 55318 Prior experience developing effective pre-market regulatory strategies. They will also provide pre-market regulatory initiatives for immunoassay devices,…
Manager, Regulatory Affairs FUJIFILM SONOSITE Tue, 15 Nov 2022 23:35:05 GMT | 21 days ago Bothell, WA 98021 Prepare various reports for executive management and internal teams, as required, to provide information on the regulatory submission activities in support of…
Regulatory Affairs Services Manager Clean Water Services Fri, 04 Nov 2022 23:24:05 GMT | 30+ days ago Hillsboro, OR 97123 6+ months of experience working in a regulatory environment. Tracks legislative and regulatory policy initiatives and trends, permitting, and emerging…
Regulatory Affairs Specialist Comtech Mon, 05 Dec 2022 18:24:39 GMT | 1 day ago Remote Manages regulatory agency updates as required. An excellent communicator, both written and verbal for coordinating with colleagues and regulatory authorities…
Senior Analyst, Regulatory Affairs Walden University Mon, 05 Dec 2022 22:34:31 GMT | 1 day ago Remote Unresolved items to manager as needed. Delegate to the manager in their absence. Represents Regulatory Affairs in institution meetings; provide regulatory…
Regulatory Affairs Specialist Unicity International Inc Tue, 29 Nov 2022 03:18:40 GMT | 8 days ago Provo, UT 84606 S. Degree in a technical field or comparable experience working in regulatory affairs is preferred. Typically reports to a supervisor or manager.
Staff Regulatory Affairs Specialist Johnson & Johnson Thu, 24 Nov 2022 08:46:31 GMT | 12 days ago Santa Clara, CA 8 years of regulatory experience in a medical device development with strong independent regulatory submissions development experience.
Regulatory Affairs Specialist TekisHub Consulting Services Wed, 30 Nov 2022 22:05:31 GMT | 6 days ago Remote Proven and relevant regulatory affairs experience in pharmaceutical, vaccine, or biological products; or related fields. Salary: $50.00 - $60.00 per hour.
CMS Regulatory Affairs TechTrueUP Fri, 21 Oct 2022 22:06:54 GMT | 30+ days ago Remote O Maintain product compliance through appropriate regulatory filings and activities including regulatory commitments. O Development of post approval variations.
Regulatory Affairs Specialist Novo Nordisk Wed, 30 Nov 2022 10:16:12 GMT | 6 days ago Plainsboro, NJ 08536 Works with manager to compose letters incorporating NN position on external regulatory initiatives. Provide proactive support and technical assistance to more…
Regulatory Affairs Associate Teva Pharmaceuticals Tue, 08 Nov 2022 04:03:13 GMT | 28 days ago District 1, WV Provide expertise and technical assessment in regulatory perspective. Prepare and compile regulatory registration filings across product lifecycles.
Regulatory Affairs Co-op Greenheck Group Wed, 30 Nov 2022 13:33:51 GMT | 6 days ago Schofield, WI 54476 Work with general managers, engineering managers, product managers and related team members to identify and develop priorities regarding opportunities and…
Associate II, Regulatory Affairs - Market Actions (Remote) ICU Medical, Inc. Thu, 13 Oct 2022 18:31:42 GMT | 30+ days ago San Clemente, CA Follows scientific arguments, identifies regulatory scientific data needs and regulatory issues with alignment of regulatory management.
Manager, Regulatory Affairs (Hybrid) Getinge Tue, 06 Dec 2022 22:53:41 GMT | 4 hours ago Merrimack, NH 03054 Designing and implementing strategies for regulatory product approvals. Assuring full regulatory compliance of all submissions and change management.
Associate, Regulatory Affairs Precision Life Sciences Mon, 05 Dec 2022 21:04:29 GMT | 1 day ago Princeton, NJ Ensure appropriate maintenance of regulatory document files. Assist SHV manager for DEA audit at the facility. Support for CBN NOC applications as needed.
Regulatory Affairs Specialist US National Institutes of Health Tue, 29 Nov 2022 03:45:37 GMT | 8 days ago Frederick, MD Skill in preparing reports and documentation on clinical trials and regulatory applications. To protect your personal information, we will only send your resume…
Senior Regulatory Affairs TekisHub Consulting Services Wed, 26 Oct 2022 19:45:14 GMT | 30+ days ago Remote Proven and relevant regulatory affairs experience in pharmaceutical, vaccine, or biological products; or related fields. Job Title: Senior Regulatory Affairs*.
Senior Analyst, Regulatory Affairs Walden University LLC Tue, 06 Dec 2022 01:42:18 GMT | 1 day ago Remote Unresolved items to manager as needed. Delegate to the manager in their absence. Represents Regulatory Affairs in institution meetings; provide regulatory…
Regulatory affairs Manager Tekskills Inc Wed, 26 Oct 2022 14:38:11 GMT | 30+ days ago Remote 6-9 years’ experience in Regulatory affairs Proven and relevant regulatory affairs experience in pharmaceutical, vaccine, or biological products; or related…
Regulatory Affairs Specialist Bimbo Bakeries USA Thu, 01 Dec 2022 19:59:48 GMT | 5 days ago Horsham, PA The Regulatory Affairs Specialist is responsible for preparing Nutritional Facts and Ingredient Statements (reg sheets) for all products within the Bimbo…
Regulatory Affairs Specialist Progressive Tue, 29 Nov 2022 21:39:21 GMT | 7 days ago Carmel, IN As a regulatory affairs specialist your role is essential to the successful processing of insurance rates, rules, and forms filings. This is a remote position.
Regulatory Affairs Strategist Navitas Life Sciences Fri, 09 Sep 2022 17:58:11 GMT | 30+ days ago Remote Ensure development programs are compliant with ICH regulatory requirements and all local country regulatory requirements. Knowledge of RoW markets is a bonus.
Specialist, Regulatory Affairs II (Remote) Quest Diagnostics Wed, 12 Oct 2022 00:38:23 GMT | 30+ days ago San Juan Capistrano, CA 92690 Keeps abreast of all regulatory registration regulations, approval processes, standards and changes. Three-four years regulatory submissions work in domestic…
Manager, Regulatory Affairs – Combination Products Pfizer Tue, 06 Dec 2022 02:24:09 GMT | 1 day ago Remote You will represent Pfizer as an approval liaison in the regulatory affairs team. Due to your expertise, you will be the regulatory liaison on the project team…
Regulatory Affairs Specialist II (Remote) Arthrex Mon, 17 Oct 2022 18:24:05 GMT | 30+ days ago Naples, FL 34108 2 years relevant experience required preferably in a regulatory affairs role in the life science industry. Advise and provide regulatory direction to assigned…
Regulatory Affairs Manager Kyowa Kirin International Fri, 29 Jul 2022 01:00:31 GMT | 4 months ago Remote Management of regulatory product information. Life science qualification with broad experience in the pharmaceutical industry, and specifically in EMEA and…
Regulatory Affairs Manager Plexus Thu, 24 Nov 2022 01:51:35 GMT | 13 days ago Remote Responsible for in depth understanding of all enterprise quality and regulatory standards, certifications, and other relevant requirements. HOW YOU WILL DO IT.
Senior Associate, Regulatory Affairs (Remote) ICU Medical, Inc. Fri, 30 Sep 2022 00:34:17 GMT | 30+ days ago San Clemente, CA Missed registration deadlines or inaccurate registration packages can delay regulatory approvals, which can result in missed sales or regulatory action…
Jobs listed on this page are currently available positions and are sourced from Indeed.com.