Full-Time Senior Regulatory Affair jobs in Mercer, NJ
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SENIOR MANAGER, REGULATORY AFFAIRS - GENERAL MEDICINE
Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development, including, but not limited to, the following: INDs/CTAs, amend...
| Company | Biospace |
|---|---|
| Address | Basking Ridge, NJ |
| Category | Information Technology |
| Job type | Full time |
| Date Posted | 2 weeks ago See detail |
Senior Manager, Regulatory Affairs - General Medicine
Biospace
Basking Ridge, NJ
Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development, including, but not limited to, the following: INDs/CTAs, amend...
2 weeks ago seen See more...
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Senior Manager CMC Regulatory Affairs
Biospace
Basking Ridge, NJ
Responsible for CMC/CP product development activities to lead the regulatory standpoint during early phase, development, submissions and post market requirements. Participate in IOPS cross-functional meetings for program-specific...
3 weeks ago seen See more...
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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...
a month 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...
2 months ago seen See more...
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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...
2 months ago seen See more...
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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...
2 months ago seen See more...
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Director, Regulatory Affairs Strategy, Hematology
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...
2 months 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...
2 months ago seen See more...
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Senior Director, Global Regulatory Intelligence & Policy
Biospace
Basking Ridge, NJ
Leads day-to-day a team of Regulatory Intelligence Policy professionals across all major regions, incl. mentorship, performance mgmt., etc. Supports the team in both Regulatory Intelligence (collection, interpretation and communic...
2 months ago seen See more...
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