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Senior Manager Regulatory Affairs
2 weeks ago
This is a fully remote opportunity to join an rapidly growing and reputable Biotech company in the Cell and Gene Therapy space.
They are seeking a Senior Regulatory Affairs Manager, experienced in biologic clinical trial applications across UK/EU and, US experience is a bonus.
Responsibilities:
- Planning, coordination, preparation, review and submission of regulatory applications and submissions.
- You will be responsible for assigned clinical studies including trial documentation, review and planning submissions.
- Coordinate, review and respond to queries from regulatory agencies.
- Support maintenance and approval of drug applications to the regulatory agencies throughout the whole lifecycle of the product.
- Ensure correct procedures are followed relating to advanced medicinal therapy products.
- Keep up to date with Cell & Gene therapy regulatory intelligence.
Requirements:
- 6-8 years of experience within the biotech and/or a pharmaceutical sector within regulatory affairs
- Proven experience in completing and submitting clinical trial applications in Europe, preferably Europe and United States.
- Experience the planning, coordination and execution of Scientific Advice or other regulatory agency meetings.
- Having experience in other key areas of the product lifecycle, such as, marketing authorisation applications (MAA's)
- Scientific and regulatory writing skills.
- Strong communication skills.
- Ability to work remotely and autonomously.