Senior Manager, Regulatory Affairs, Advertising & Promotion
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Job Description
Senior Regulatory Affairs Manager guiding pharmaceutical advertising and promotion compliance at Regeneron. Advising commercial, medical, legal, and FDA stakeholders across marketed and pipeline products.
Responsibilities:
- Manage US and Global, if applicable, regulatory activities associated with advertising and promotion of marketed products and commercial development of pipeline products
- Manage commercial activities from a regulatory advertising and promotion perspective with minimal guidance
- Advise on development of product messages and materials across multiple functional areas
- Provide regulatory advice and guidance to Commercial teams and Medical Affairs regarding conference exhibits, disease awareness, and speaker programs
- Review US and Global product and disease-state materials and communications for compliance with applicable laws, regulations, and guidance
- Collaborate with Marketing, Medical Affairs, Legal, and other key stakeholders
- Establish working relationships and manage communication with regulatory advertising and promotion professionals at co-promote partner companies
- Help lead interactions with FDA Office of Prescription Drug Promotion (OPDP), including advisory submissions
- Maintain compliance with promotional material submissions to FDA on Form 2253
- Monitor evolving regulatory requirements related to product and disease-state communications
- Monitor FDA promotional enforcement activities and advise stakeholders on their impact
- Provide input on process improvements and portfolio-wide standardization of promotional review policies
- Cross-train across products and indications to ensure continuous Regulatory Advertising and Promotion support
- Collaborate with Regulatory Therapeutic Area Leads on marketing application summary documents and study reports
- Support review cycles to reflect commercialization objectives and messages in submission documents and reports
- Provide input during labeling development and negotiation to reflect commercialization objectives and messages impacting promotion and advertising
Requirements:
- Minimum of 3 to 4 years within regulatory affairs, preferably within advertising and promotion
- At minimum, a Bachelor’s degree from an accredited College or University in Life Sciences
- Regulatory experience can offset education requirements
- Advanced knowledge of regulations, guidelines, and precedents related to pharmaceutical product development and marketing, with focus on advertising and promotion
- Experience with pharmaceutical products required; biologics experience is a plus
- Experience working directly or indirectly with the FDA, specifically OPDP/APLB, preferred
- Ability to review promotional materials and interact with FDA OPDP/APLB
- Experience managing launch products/campaigns
- Excellent written and verbal communication skills when providing strategic regulatory advice
- Ability to support global promotional review
- Understanding of clinical trial recruitment materials
- Familiarity with labeling regulations desirable
- Ability to influence cross-functional teams and interact with senior management
Benefits:
- Annual bonuses or other incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Medical, dental, vision, life, and disability insurance benefits
- Paid time off
- Family support benefits
- Reasonable accommodation during the recruitment process where required
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