Regulatory Affairs Manager jobs in Flemington, NJ
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MANAGER GLOBAL CMC REGULATORY AFFAIRS
Develops and realize global regulatory strategies for development compounds and marketed products according to scientific and risk-based principles. Participates as regulatory lead on CMC/VCM teams and represents CMC RA by provid...
| Company | Johnson & Johnson |
|---|---|
| Address | Titusville, NJ |
| Category | Information Technology |
| Date Posted | 2 weeks ago See detail |
Manager Global CMC Regulatory Affairs
Johnson & Johnson
Titusville, NJ
Develops and realize global regulatory strategies for development compounds and marketed products according to scientific and risk-based principles. Participates as regulatory lead on CMC/VCM teams and represents CMC RA by provid...
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Associate Manager, Regulatory Affairs
Kenvue
Skillman, NJ
Understand the Regulatory landscape for Consumer products and effectively manage regulatory priorities and timelines for marketed products and will support regulatory strategy for innovative projects across many regulatory classif...
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Associate Manager, Regulatory Affairs
Johnson & Johnson Consumer Inc.
Skillman, NJ
Understand the Regulatory landscape for Consumer products and effectively manage regulatory priorities and timelines for marketed products and will support regulatory strategy for innovative projects across many regulatory classif...
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Senior Manager, Product Communications and Public Affairs, Pulmonary Hypertension New
Johnson & Johnson
Titusville, NJ
Develop and implement innovative communication and Public Affairs strategies and programs in support of brand business objectives for UPTRAVI, OPSUMIT, OPSYNVI. Lead the growth of unbranded social communities and content creat...
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Manager - Regulatory Affairs - Therapeutic Area
Biospace
Plainsboro, NJ
Compile and submit responses to FDA communications. MANAGER, THERAPEUTIC AREA: Compile, submit and maintain applications (IND, NDA, Biologics, Devices) to government agencies in support of research and marketed products. Create an...
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SENIOR MANAGER REGULATORY AFFAIRS
Tk-Chain Llc
Princeton, NJ
$80,000 - $170,000 a year
Ensures that appropriate CMC regulatory activities occur in support of both pre and post-approval submissions while meeting aggressive timelines and adhering to the highest quality standards. Must be able to effective articulate c...
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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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Regulatory Affairs Associate - Drug Products (Princeton, NJ (USA), US)
Laboratoire Guerbet
Princeton, NJ
Participate in pre-submission meetings with FDA in order to agree on potential regulatory pathways, clarification and follow-up of submissions under review. Coordinate preparation, review, submission of e-CTD regulatory dossiers t...
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Associate Director, Regulatory Affairs
Johnson And Johnson
Somerville, NJ
Bring innovative regulatory approaches, deeply rooted in science, to lead the team in discussions with FDA and Health Canada to find the best development strategies for novel therapies in the areas where no other precedents exist....
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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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Associate Director / Director, Regulatory Affairs (Generic Medicines)
Cnam - Auditeurs - Accueil
Princeton, NJ
This role will work directly with the development and maintenance teams on the product registrations, through FDA communication and review process, amendments, supplements, and annual reports. Coordinates, reviews, and may prepare...
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Associate Director, Regulatory Affairs - Labeling: Job ID - 1297NJ
Ascendis Pharma
Princeton, NJ
Medical insurance. Vision insurance. Dental insurance. 401(k). Paid maternity leave. Paid paternity leave. Commuter benefits. Disability insurance....
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Associate Director, Regulatory Affairs
Bausch + Lomb
Bridgewater, NJ
Provide Regulatory support and guidance in the development, revision, review, and approval of labeling artwork for Health Authorities submissions, as well as any post marketing labeling changes. Responsible for post approval lifec...
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Manager Regulatory Operations
Biospace
Bridgewater, NJ
Support regulatory submission activities associated with generating electronic submissions in support of IND/NDA applications. Responsible for the archival of submission and submission related documents in the EDMS. Contribute to...
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