Regulatory Affairs Director
2 days ago
**About the Role**
We are seeking a highly experienced Regulatory Affairs Director to lead our EU regulatory strategy and ensure compliance with global regulations.
The successful candidate will have a strong understanding of the EU regulatory environment and be able to develop and implement effective strategies to obtain and maintain product licenses.
Key Responsibilities:
- Develop and implement regulatory strategies for EU and global markets
- Provide guidance on regulatory requirements and ensure compliance across all product portfolios
- Liaise with health authorities, including EMA and MHRA
- Lead cross-functional teams to resolve complex project issues
Requirements
- 12+ years of experience in Regulatory Affairs, preferably in biotechnology or pharmaceutical industry
- Strong knowledge of EU and global regulations, including ICH, FDA, HC, UK, and EU regulations
- Excellent strategic thinking, diplomacy, negotiation, and communication skills
About Emergent Biosolutions
We are a leading biopharmaceutical company focused on protecting and enhancing 1 billion lives by 2030. Our mission is to improve the quality of life for individuals around the world by developing innovative products that address unmet medical needs.
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