Senior Regulatory Affair jobs in Mercer, 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 | a week 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...
a week 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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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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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 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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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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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...
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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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 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...
3 weeks 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...
4 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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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...
2 months ago seen See more...
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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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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...
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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...
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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...
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....
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Associate Director, US Regulatory Affairs Strategy
Daiichi Sankyo, Inc.
Basking Ridge, NJ
Develop and implement US regulatory strategy for assigned project(s). Strategize and plan for FDA meetings for assigned product. Liaise, negotiate and orchestrate meetings with FDA. Prepare internal meeting minutes to capture the...
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