Associate Manager, Regulatory Advertising & Promotion

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $109.9k - $179.3k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚔 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

• Contribute to management of US regulatory activities associated with advertising and promotion of marketed products • Manage commercial activities from a regulatory advertising and promotion perspective with guidance from the Regulatory Affairs, Advertising & Promotion Director • 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 • Collaborate with Marketing, Medical Affairs, Legal, and other key stakeholders • Manage communication with regulatory advertising and promotion professionals at co-promote partner companies • Assist with interactions with the FDA Office of Prescription Drug Promotion (OPDP), including advisory submissions • Maintain compliance with promotional material submissions to the FDA on Form 2253 • Monitor evolving regulatory requirements for product and disease-state communications • Monitor FDA promotional enforcement activities and assess impacts on company policies • Support process improvement and portfolio-wide standardization of promotional review policies • Provide continuous Regulatory Advertising and Promotion support to stakeholders • Collaborate with Regulatory Therapeutic Area Leads to review marketing application summaries and study reports • Support commercialization objectives and messaging in regulatory submission documents and reports • Work with management during labeling development and negotiation to reflect commercialization objectives affecting promotion and advertising

🎯 Requirements

• A minimum of 1 to 2 years within regulatory affairs, preferably within advertising and promotion, or completion of a Post-Doctoral Fellowship Program with related Regulatory Affairs experience • Minimum requirement is a Bachelor's degree (BS) from an accredited college or university in Life Sciences • Advanced scientific degree (Masters, PharmD, or Ph.D.) strongly preferred • Fundamental understanding of regulations, guidelines, and precedents related to pharmaceutical product development and marketing, focused on advertising and promotion • Experience with pharmaceutical products highly preferred; biologics experience is a plus • Experience working directly or indirectly with the FDA, specifically OPDP/APLB, is desirable • Ability to review promotional materials and interact with FDA OPDP/APLB • Ability to support launch products and campaigns • Excellent written and verbal communication skills • Familiarity with global promotional review, clinical trial recruitment materials, and labeling regulations is desirable • Ability to influence and guide cross-functional teams • Ability to interact effectively with senior management and colleagues at all levels

🏖️ 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