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Global Regulatory Affairs Lead
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Full-time
- The Global Regulatory Affairs Lead (GRL) is the fully accountable decision maker for the development & execution of creative, thoughtful, and robust global regulatory strategies for their products in Sanofi's diversified portfolio in order to meet corporate and business objectives.
- The role is responsible for assessing and interpreting the global regulatory and competitive environments and accountable to ensure that it leverages expertise in commercial competitive intelligence and other parts of GRA (e.g. Regional experts and Regulatory Science and Policy) in order to ensure the most robust strategy possible and is accountable for determining any updates to the regulatory strategy accordingly
- Significant leadership experience in developing innovative regulatory strategies supporting the clinical development of drugs and/or innovative biologics products
- Advanced degree (PharmD, PhD, MD or DVM or MSc in Biology, Life Science, or related field) is preferred
- At least 10-12 years of relevant pharmaceutical/biotechnology experience, including at least 10 years of relevant Regulatory Affairs experience (regionally and global), in early and late stage development of multiple modalities; experience within regulatory CMC not directly applicable
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