Sr Director, Regulatory Affairs - Advertising, Promotion, and Labeling
May 31
🏢 In-office - Bay Area
Description
• Lead the development and implementation of regulatory strategies for commercial and corporate communications • Manage regulatory labeling for Phase 3 and commercial assets • Review and approve product labeling, promotional claims, and advertising • Represent the company in key regulatory meetings and support global regulatory inspections and approval strategies
Requirements
• BA/BS Degree in health/life sciences or related field. Advanced degree (PharmD, PhD, MS) highly preferred • 12+ years of Regulatory Ad/Promo experience • Experience managing commercial regulatory strategy and labeling • Experience leading interactions with health authorities (US and ex-US) • Understanding of US FDA regulations and international regulatory agencies • Regulatory experience that includes IND/CTA, NDA/BLA/MAA, lifecycle management, and complex regulatory strategies • Excellent project management, negotiating, and communication skills
Benefits
• Competitive salary • Comprehensive benefits package including medical, dental, and vision coverage • 401(k) retirement plan with company match • Paid time off and holidays
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