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Boston, MA (88)
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San Francisco, CA (66)
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5-7 years (1,308)
8-10 years (931)
11-14 years (914)
15+ years (208)
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Merck & Co, Inc (54)
Sanofi Pasteur (31)
Johnson & Johnson (29)
Easy Apply only
Provide regulatory guidance, risk assessment and management throughout the product lifecycle: New Product Development and Commercial projects. Manage and implement Regulatory Affairs strategies, polic...
Documented excellent written and oral communication skills; technical writing capabilities are a must. Demonstrated ability to work successfully and communicate effectively within a cross-functional t...
Manage and track queries and commitments with regulatory agencies, collaborate with subject matter experts to provide written responses to queries, provide periodic status updates regarding unfulfille...
Oversee Operations functions within CMC, including but not limited to defining specifications, trending, and analyzing batch data, maintain internal and external CMC documents, and supporting and defi...
Author and/or review portions of key regulatory submissions such as INDs / CTAs, meeting requests, briefing documents and responses to Health Authority questions, Develop and maintain relationships wi...
Provide regulatory leadership as needed in product in-license/due diligence review, product divestment and product withdrawal.
The individual will work closely with the global Biopharm Regulatory Affairs (BRA) Leads to provide critical US perspective for regulatory strategies (precedents), provide regulatory guidance, critica...
Responsible for the preparation of regulatory submissions which require interaction with cross-functional teams for investigational and marketed products for US and international regions in line with...
Lead the Clinical/Nonclinical Regulatory team, ensuring that budget, resources, best practices, and planning are in-place to support the creation of high-quality, on-time submissions. Oversee the deve...
Oversight of the regulatory status of products against customer standards and uses determined by team members; ensures effective communication of regulatory information to meet BU performance targets...
Strong knowledge and experience with OTC, cosmetic and/or consumer product regulatory frameworks, with emphasis in the region of North America (US/CAN). Monitor and interpret changes in laws, standard...
Partner with customers and internal stake holders to provide the information necessary to support customer regulatory filings. Proactively work with VVS SMEs and responsible quality personnel to provi...