Senior Manager, Regulatory Labeling

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May 6

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Regeneron

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Biotechnology • Pharmaceuticals • Healthcare Insurance

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.

10,000+ employees

Founded 1988

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

💰 Post-IPO Equity on 2023-10

📋 Description

• Manages the development, review, approval, and maintenance of the Company Core Data Sheets (CCDS), USPI, EU SmPC and Rest of World (RoW) labeling. • Provides labeling expertise to the Labeling Working Group and other relevant stakeholders, typically carrying out responsibilities with minimal guidance. • Leads development of labeling strategies and is responsible for the management of marketed or pipeline products, across the product lifecycle. • Managing the Regulatory labeling process throughout the product lifecycle. • Leading the Labeling Working Group and manages development, review, approval, and maintenance of labeling for CCDS, USPI, EU SmPC, and RoW labeling. • Manages complex programs with minimal support from the Labeling Director. • Leading development of labeling strategies through interpretation of labeling regulations, guidelines and competitor analyses, and application to product situation. • Leading the development of target labeling documents to support the design and analysis plan for clinical trials, with guidance from the Labeling Director. • Leading or contributes to discussions on labeling topics at relevant management interactions. • Effectively communicates labeling rationales to various levels of management to enable decision making. • Providing labeling expertise on complex issues to stakeholders. • Anticipates Health Authority (HA) perspectives and broader implications of strategies, proposing alternatives and providing advice to mitigate risk. • Communicates consequences to product portfolio. • Preparing submission-ready labeling documents. • Maintains labeling documents in the electronic document management system and relevant labeling trackers as appropriate. • Contributing to the development of the Regulatory Labeling Group through active knowledge sharing and mentoring of junior staff members to build labeling expertise. • Monitoring worldwide regulation changes pertaining to Labeling regulations and maintains the labeling SOP and work instructions. • May be responsible for leading or contributing to various continuous improvement projects.

🎯 Requirements

• At minimum, a Bachelor’s degree (BS) from an accredited college or university in Life Sciences. • Advanced degree (Masters, Pharm D, Ph.D, MD or DO) preferred in the field of medicine or science. • Regulatory experience can offset education requirements. • 3 - 4+ years of related Biotech or Pharma industry experience, 2 or more of which are working with labeling is preferred. • In-depth knowledge of the labeling process, industry practice, packaging manufacturing process, and the drug development process. • Familiar with policies and operating procedures in medical safety regulatory and/or corporate and worldwide Regulatory Agencies. • Expert knowledge of FDA, EMA, and international labeling regulations, ICH guidelines, and CIOMS core labeling guidelines.

🏖️ Benefits

• health and wellness programs • fitness centers • equity awards • annual bonuses • paid time off for eligible employees