Senior Manager, Regulatory Affairs, Advertising & Promotion

Regeneron · Warren +1 more

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RegulatoryFull-time$151k–$246kCompany career page

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What they're looking for

3-4 years regulatory affairs experience, preferably in advertising and promotion
Bachelor's degree in Life Sciences; advanced degree preferred
Advanced knowledge of pharmaceutical advertising and promotion regulations and guidelines
Experience with pharmaceutical products; biologics experience preferred
FDA experience, specifically OPDP/APLB interaction, preferred
Strong written and verbal communication skills for regulatory advice
Ability to influence cross-functional teams and interact with senior management

What you'll be doing

Manage US and global regulatory activities for marketed product advertising and promotion
Advise on development of product messages and materials across functional areas
Provide regulatory guidance to Commercial and Medical Affairs teams on conference exhibits and speaker programs
Review and approve US and global product and disease state materials for compliance
Lead FDA OPDP interactions and manage promotional material submissions on Form 2253

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Date posted17 days ago

Last source check1 day ago

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