Regulatory Affairs Manager jobs in Hunterdon, NJ
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SENIOR MANAGER CMC REGULATORY AFFAIRS
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...
| Company | Biospace |
|---|---|
| Address | Basking Ridge, NJ |
| Category | Information Technology |
| Job type | Full time |
| Date Posted | 2 days ago See detail |
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...
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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...
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Associate Director, Regulatory Affairs (Advertising and Promotion)
Bausch Health
Bridgewater, NJ
Provides regulatory review of Advertising and Promotional materials, new campaigns and launch strategies for assigned products. Assures timely and accurate review of Advertising and Promotional material to meet internal timelines...
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Senior Manager Regional Regulatory Affairs
Biospace
King Of Prussia, PA
You will be the primary CSL representative to regional health authorities for assigned products.. Develop the establishment and maintenance of high quality relationships with regional health authorities and collaborating with resp...
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Manager, Regulatory Affairs
Biospace
King Of Prussia, PA
You will plan, direct, and monitor Regulatory Affairs activities so we have the permits, licenses, certificates, authorizations, and other approvals needed to conduct our business activities; and produce, sell, and distribute its...
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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...
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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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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...
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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...
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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...
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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...
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Director, Global Regulatory Affairs (GRL)
Biospace
Basking Ridge, NJ
Manages, directs, and drives the strategy for all Regulatory activities associated with the registration and support of new and approved drug products. Seeks and incorporate regional and functional RA strategy into a global strate...
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Director, Regulatory Affairs Companion Diagnostics
Biospace
Basking Ridge, NJ
CDx development: Provide critical strategic and tactical regulatory guidance for CDx/IVD development and CDx submission plan for each country/region, both before and after CDx testing. At the time of implementation of a CDx study/...
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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...
4 weeks ago seen See more...
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...
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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...
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