Regulatory Affairs Expert
2 weeks ago
- As a CMC Regulatory Strategist, you will be responsible for developing global CMC regulatory strategy, driving global CMC RA related activities, and successfully executing regulatory strategies in collaboration with stakeholders.
- You will also be supporting business-critical interactions inside and outside of Astellas Regulatory Affairs on complex CMC issues and questions in collaboration with local and global stakeholders.
Key Responsibilities:
- Acts as a CMC regulatory lead/expert for global projects, ensuring compliance with EMA/FDA/ICH/global regulations.
- Manages preparation and review of global registration packages, ensuring effective data presentation and regulatory compliance.
- Defines and implements regulatory strategies for global registrations, variations, and health authority responses.
What We Offer
A competitive salary of £80,000 per annum, depending on experience, plus benefits including a hybrid working model, allowing you to work from home or in our office based in the United Kingdom. We are an equal opportunity employer and welcome applications from all qualified candidates.
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