Senior Manager, Regulatory Affairs, Advertising & Promotion

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $150.5k - $245.5k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Regeneron

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1988

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

💰 Post-IPO Equity on 2023-10

Healthcare • Manufacturing • Biotechnology

Regeneron is a biotechnology company dedicated to turning scientific discoveries into life-changing medicines. The company focuses on a range of serious diseases including allergic, cardiovascular, and metabolic diseases, neuroscience, oncology, hematology, ophthalmology, and rare diseases. It achieves this by integrating biology and technology to develop cutting-edge biologics and genetic medicines. Regeneron is committed to health equity, environmental sustainability, and supporting future STEM talent through initiatives like the Regeneron Science Talent Search. By maintaining high ethical standards and corporate responsibility, Regeneron aims to push the boundaries of science for better healthcare solutions.

📋 Description

• 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