Regulatory Affairs Specialist
3 weeks ago
We are seeking an experienced regulatory professional to lead our CMC strategy efforts. This hybrid role is based in London, United Kingdom, with a flexible schedule and monthly office visits.
Main Responsibilities:- Develop innovative CMC regulatory strategies and plans
- Lead the preparation and review of regulatory documents, including INDs, IMPDs, MAAs, etc.
- Represent clients in regulatory agency interactions and negotiations
- Oversee project timelines, budgets, and deliverables
- Mentor and manage team members, providing training and technical leadership
- Contribute to business development through client relationships and identifying new opportunities
- Stay ahead of regulatory trends and ensure compliance with evolving standards
Requirements:
- Minimum 8 years of experience in drug development and regulatory affairs
- Proven experience with FDA, EMA, and/or MHRA processes
- Expertise in biologics, ATMPs, vaccines, or small molecules
- Advanced degree in life sciences (MSc or PhD preferred)
- Strong leadership, organizational, and time management skills
Estimated salary: £100,000 - £120,000 per annum.
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Regulatory Affairs Specialist
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