Manager, Regulatory Affairs, Advertising & Promotion

🕒 6 days ago

🇺🇸 United States – Remote

💵 $128.6k - $210k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

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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 regulatory activities associated with advertising and promotion of the company’s marketed products • Manage commercial activities from a regulatory advertising and promotion perspective with guidance from the Regulatory Affairs, Advertising & Promotion Director • Contribute to and advise on the development of product messages and materials across multiple functional areas • Provide regulatory advice and guidance to Commercial teams and Medical Affairs regarding conference exhibit activities, 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 • Establish working relationships and manage communication with regulatory advertising and promotion professionals at co-promote partner companies • Help lead and assist in interactions with the FDA Office of Prescription Drug Promotion (OPDP), including advisory submissions • Maintain effective communication with FDA OPDP reviewers on advertising and promotion matters • Ensure compliance with promotional material submissions to FDA on Form 2253 • Monitor the external environment and advise product teams on evolving regulatory requirements • Monitor FDA promotional enforcement activities and update stakeholders • Provide guidance on the impact of enforcement activities on company policies • Identify process improvements for promotional review activities and portfolio-wide policy standardization • Cross-train across products and indications to ensure continuous Regulatory A&P support • Collaborate with Regulatory Therapeutic Area Leads to review marketing application summary documents and study reports • Provide input during review cycles to reflect commercialization objectives and messages in submission documents and reports • Provide input during labeling development and negotiation regarding commercialization objectives and messages impacting promotion and advertising

🎯 Requirements

• A minimum of 2 total years relevant experience, preferably within Regulatory Advertising and Promotion • At minimum, a Bachelor's degree from an accredited college or university in Life Sciences • Knowledge of regulations, guidelines and precedents related to pharmaceutical product development and marketing, with focus in advertising and promotion • Experience with pharmaceutical products required; biologics experience is a plus • Experience working directly/indirectly with the FDA, specifically OPDP/APLB, is preferred • Ability to review promotional materials and interact with FDA OPDP/APLB • Ability to support launch products/campaigns while maintaining excellent written/verbal communication skill when giving strategic regulatory advice • Ability to support global promotional review • Understanding of clinical trial recruitment materials • Familiarity with labeling regulations is desirable • Ability to influence cross-functional teams and work collaboratively with colleagues at all levels • Ability to interact with senior management if needed

🏖️ 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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