Full-Time 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 | 3 weeks 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...
3 weeks 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...
4 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...
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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...
2 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...
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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...
a month ago seen See more...
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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...
a month ago seen See more...
- View all Biospace jobs - jobs in Plainsboro, NJ
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...
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