Senior Regulatory Affair jobs in Princeton, NJ
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SENIOR ASSOCIATE - REGULATORY AFFAIRS
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...
| Company | Biospace |
|---|---|
| Address | Princeton, NJ |
| Category | Information Technology |
| Job type | Full time |
| Date Posted | 5 days ago See detail |
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...
5 days ago seen See more...
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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...
2 months ago seen See more...
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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...
3 weeks ago seen See more...
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Senior Director, Global Medical Affairs Strategy - Solid Tumors
Genmab A/S
Princeton, NJ
Develop and execute the overall Medical Affairs Strategy for designated product in NSCLC therapeutic area. Serve on Compound Development Team as Global Medical Affairs representative; Co-Lead Global Commercialization Team. Serve a...
3 weeks ago seen See more...
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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...
4 weeks ago seen See more...
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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...
2 months ago seen See more...
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Senior Manager, Product Communications and Public Affairs, Pulmonary Hypertension
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...
2 weeks ago seen See more...
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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...
3 weeks ago seen See more...
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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...
3 weeks ago seen See more...
- View all Biospace jobs - jobs in Plainsboro, NJ
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...
3 weeks ago seen See more...
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USA Regulatory Affairs Specialist Project Lead I Scientific
Adecco
Bridgewater, NJ
$ 88 - $ 89.22 / Hour
Adecco Medical & Science is hiring a remote contract Regulatory Affairs Team Lead for our Pharmaceutical partner based out of Bridgewater, NJ.The anticipated wage for this position is between $88 and $89.22. A possible meeting in...
7 days ago seen See more...
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Senior Administrator-Medical Affairs
Biospace
Plainsboro, NJ
Independently researches a wide variety of information requests and gathers and compiles reports. Directs administrative activities, develops and organizes procedures, and uses considerable written and verbal communication skills...
3 weeks ago seen See more...
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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...
2 months ago seen See more...
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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...
2 months ago seen See more...
Global Corporate Affairs, Senior Financial Analyst
Johnson & Johnson
New Brunswick, NJ
Prepare visual presentations of financial concepts for senior management. This includes developing complex financial graphs and charts. Examine existing financial concepts to identify areas for operational improvement, including...
2 weeks ago seen See more...
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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...
2 months ago seen See more...
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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....
2 months ago seen See more...
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