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European Regulatory Strategy Manager
3 weeks ago
The Director, Regulatory Affairs will be responsible for leading the development and implementation of regulatory strategies for Emergent's product portfolio. This role will also provide regulatory guidance to cross-functional groups regarding manufacturing, quality, preclinical and clinical development and testing for products with a focus on EU and/or UK requirements.
Key Performance Indicators:
- Develop and implement regulatory strategies that ensure compliance with EU and global regulations
- Provide timely and effective regulatory support to cross-functional groups
- Maintain a high level of knowledge of EU and global regulations and guidances
- Collaborate with project teams to resolve complex project issues
Requirements:
- Bachelor's degree in a related biological and life sciences field (Master's or Ph.D. preferred)
- Years of experience directly related to Regulatory Affairs in biotechnology or pharmaceutical industry
- Knowledge of EU and global regulations/guidances and thorough knowledge of biological/drug development process
- Strong strategic and critical thinking, diplomacy, negotiation and excellent oral and written communications skills
- Ability to understand and apply technical materials and regulations, strong technical writing skills, knowledge of CMC, clinical and non-clinical pharmaceutical development
- Possess a broad knowledge of biopharmaceutical manufacturing and operations
- Demonstrated people-leader skills and evaluation of performance
