Senior Manager Regulatory Affairs

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.