Full-Time Regulatory Affair Manager jobs in Somerville, 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 days 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 days 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...
7 days 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...
3 weeks 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...
a month 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...
a month 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...
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...
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Clinical Trial Manager, Global Oncology Medical Affairs
Biospace
Basking Ridge, NJ
Support the preparation, set-up, and execution and reporting of all Global Oncology Medical Affairs operations Clinical Trial activities, ensuring adherence to timelines, budgets, project, and quality plans, and relevant ICH/GCP G...
2 months 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...
4 weeks 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...
a month 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...
2 months ago seen See more...
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Summer 2024 - Regulatory Portfolio Management Internship
Bristol-Myers Squibb Company
Princeton, NJ
Co-lead GRST meetings in alignment with the GRS Culture Playbook to ensure high quality discussions & decisions; diligent follow-up with sub-team members to uphold accountabilities and drive decision making, project availability d...
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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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