Regeneron
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
Senior Manager - CMC Regulatory Affairs
March 28
Regeneron
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
• responsible for developing and executing regulatory strategies for biologic products • responsible for CMC product development activities from a regulatory standpoint • provide regulatory interpretation, position and strategy for global CMC/CP regulatory portfolios • proactively identify program issues and develop appropriate regulatory strategies to mitigate risks • critically review and provide strategy input on regulatory filing documents • lead and facilitate activities for meetings with FDA, EMA and other regulatory authorities • perform the compliance activities of the portfolio to determine regulatory impact
🎯 Requirements
• good understanding of current CMC RA worldwide regulations for advanced therapy medicinal products • proven track record of supporting biological products/advanced therapies through development and approval • experience in delivering CMC sections of marketing authorizations and post-approval submissions for biologic products • expertise in gene therapies • experience in dealings with FDA, EMA and other regulatory authorities
🏖️ Benefits
• health and wellness programs • fitness centers • equity awards • annual bonuses • paid time off
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