Full-Time Regulatory Affair jobs
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SR. REGULATORY AFFAIRS SPECIALIST (ANDOVER OR MANSFIELD, MA)
Coordinates associated registration or submissions leading to market clearance/approval. Provide regulatory direction to project teams for product development/design control related activities. Drafting, authoring and submitting P...
| Company | Smith & Nephew |
|---|---|
| Address | Andover, MA |
| Category | Information Technology |
| Salary | $115,000 - $130,000 a year |
| Job type | Full-time |
| Date Posted | just now See detail |
Sr. Regulatory Affairs Specialist (Andover or Mansfield, MA) New
Smith & Nephew
Andover, MA
$115,000 - $130,000 a year
Coordinates associated registration or submissions leading to market clearance/approval. Provide regulatory direction to project teams for product development/design control related activities. Drafting, authoring and submitting P...
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Associate Director, Regulatory Affairs Innovation New
Biospace
Irvine, CA
Leads and/or supports medical device / pharma development, including Clinical Outcome Assessment tools and Digital Health Technologies, and global filing activities from a regulatory standpoint from initial product concept through...
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Senior Manager/Associate Director, Regulatory Affairs, Strategic Global Labeling - Combination New
Biospace
North Chicago, IL
Develop and direct strategic regulatory planning, creation, and revision of labeling for combination product and device submissions (pre and post approval) with an understanding of Global requirements to lead the Labeling Sub team...
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Senior Specialist Regulatory Affairs - Nutrition - Lake County , IL or Columbus, OH New
Abbott Laboratories
Lake Forest, IL
$72,700 - $145,300 a year
Training and career development, with onboarding programs for new employees and tuition assistance Financial security through competitive compensation, incentives, and retirement plans Health care and well-being programs including...
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Senior Associate - Regulatory Affairs
Biospace
Princeton, NJ
Contribute to the preparation, review, approval, and dispatch of global submissions to regulatory applications (pre-submission activities, orphan drug applications, IND/INDs/CTAs/NDAs/MAAs etc.). Support the planning and conduct o...
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Senior Manager, Regulatory Affairs Vendor Governance
Biospace
California, United States
Own initiatives and day to day responsibilities in support of vendor oversight within RA. Negotiation and problem solving between Gilead RA leads and Vendor resources. Able to gather information or assign tasks or activities for o...
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Regulatory Affairs Manager (CMC Site)
Biospace
New Albany, OH
Facilitate product development, global registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle.. Provi...
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Manager, Global Regulatory Affairs CMC
Biospace
Boston, MA
I further attest that all information I submit in my employment application is true to the best of my knowledge.Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC in Cambridge, MA with the...
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Regulatory Affairs Consultant
Katalyst Healthcares And Life Sciences
Rahway, NJ
Develop global regulatory strategies for medical device products to meet business objectives and collaborates across a matrixed organization to ensure global success of products' registration. Participate on product development te...
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Regulatory Affairs Consultant
Katalyst Healthcares & Life Sciences
Rahway, NJ
Develop global regulatory strategies for medical device products to meet business objectives and collaborates across a matrixed organization to ensure global success of products\' registration. Participate on product development t...
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Counsel, Head of Global Regulatory Affairs
An Asset Management Company
Los Angeles, CA
Coordinate TCW's engagement with regulators and other policymakers on Global Regulatory matters, including representing TCW in such engagements. Position TCW to influence policy and regulations; consider TCW's clients and business...
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Manager, Regulatory Affairs CMC - Now Hiring
Takeda Pharmaceutical
New York, NY
The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, c...
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Director, Regulatory Affairs
Byheart
New York, NY
The only U.S.-made infant formula to use organic, grass-fed whole milk. The first and only U.S. infant formula company to add the two most abundant proteins found in breast milk-alpha-lac and lactoferrin-to our ingredients list. T...
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Sr. Specialist, Regulatory Affairs CMC
Biospace
United States
Prepare content of CMC documentation for large and small molecule product submissions to regulatory agencies (FDA/EMA), ensuring accuracy, completeness, and consistency with strategy. Review and edit final documents for regulatory...
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Sr. Director, Regulatory Affairs
Biospace
San Diego, CA
Develop, implement and maintain regulatory and quality assurance strategies and activities for AnaptysBios pipeline programs. Serve as the FDA contact, leading creative and constructive interactions with regulatory agencies...
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Director, Regulatory Affairs Strategy - Genetic Medicine
Biospace
New York, NY
Provide interpretation of regulatory authorities feedback, policies and guidelines.. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...
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Associate Director, Regulatory Affairs - Inflammation & Immunology
Biospace
New York, NY
Provide interpretation of regulatory authorities feedback, policies and guidelines.. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...
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Associate Director, Regulatory Affairs - Inflammation & Immunology
Biospace
New York, NY
Provide interpretation of regulatory authorities feedback, policies and guidelines.. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...
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Director, Regulatory Affairs Strategy - Genetic Medicine
Biospace
Basking Ridge, NJ
Provide interpretation of regulatory authorities feedback, policies and guidelines.. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...
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Associate Director, Regulatory Affairs Advertising and Promotion
Biospace
California, United States
Provides commercial regulatory support to high-volume brands or therapeutic area and projects without managerial oversight, as appropriate. Reviews and approves promotional materials.. Serves as PRC Chair for one or more high-volu...
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Associate Director, Regulatory Affairs - Inflammation & Immunology
Biospace
Basking Ridge, NJ
Provide interpretation of regulatory authorities feedback, policies and guidelines.. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...
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Director, Regulatory Affairs Strategy - Genetic Medicine
Biospace
New York, NY
Provide interpretation of regulatory authorities feedback, policies and guidelines.. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...
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Associate Director, Regulatory Affairs Strategy - Genetic Medicine
Biospace
New York, NY
Provide interpretation of regulatory authorities feedback, policies and guidelines.. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...
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Regulatory Affairs Manager - Now Hiring
Abbott Laboratories
Texas, United States
$95000 - $190000 per year
Develops sound global regulatory strategies for new and modified medical devices. Prepares robust regulatory applications to achieve departmental and organizational objectives. Creates, reviews and approves engineering changes. Pr...
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Manager, Global Regulatory Affairs CMC Submissions Management
Takeda Pharmaceutical
Bronx, NY
$138,500 - $186,000 per year
I further attest that all information I submit in my employment application is true to the best of my knowledge.Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC Submissions Management in...
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Associate Director - Regulatory Affairs - AD Promo
Biospace
Princeton, NJ
Provide strategic guidance for responsible products and disease states based on current regulatory environment and competitive landscape. Assess risk and advise on mitigation strategies to meet overall business need, while maintai...
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Director, Regulatory Affairs, Oncology - Job ID: 1311
Ascendis Pharma
Palo Alto, CA
Medical insurance. Vision insurance. Dental insurance. 401(k). Paid maternity leave. Paid paternity leave. Commuter benefits. Disability insurance. Life Insurance (Basic, Voluntary & AD&D)....
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Director, Clinical Regulatory Affairs
Cymabay Therapeutics
Newark, CA
Work with Vice President to devise regulatory strategies to ensure rapid and timely approval of products. Develop global regulatory plans to facilitate the progress of programs in all phases of development. Identify risk mitigatio...
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Certification and Licensing Coordinator, Regulatory Affairs, Full time, Days
Pih Health
Los Angeles, CA
Effective written/oral communication, and presentation skills. Problem-solving skills. Strong knowledge of performance improvement tools and techniques. Proficient computer literacy. California RN License. Bachelors Degree in hea...
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Specialist - Regulatory Affairs
Biospace
Plainsboro, NJ
Therapeutic Area:. Assist Manager/Director in review of labeling for marketed products and new products as assigned. Maintain up-to-date knowledge of data requirements and formats, applicable current SOPs, regulations, and guideli...
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