Regulatory Affairs Director

22 hours ago


Nottingham, Nottingham, United Kingdom Discover International Full time

Discover International is seeking a highly skilled Senior Manager Regulatory Affairs to lead regulatory strategies for cell and gene therapy products. This role involves ensuring compliance with global regulatory requirements, providing strategic regulatory guidance, and interacting with regulatory agencies.

About the Role
  • This position requires a proven track record of leading regulatory submissions and obtaining approvals for advanced therapies.
  • The successful candidate will have extensive experience interacting with major global health authorities, including the FDA and EMA.
  • This is an exciting opportunity for a motivated individual to take on a senior leadership role in our Regulatory Affairs team.

We estimate that the annual salary for this position is around $150,000 - $180,000, depending on location and experience.

Key Responsibilities
  1. Develop and execute comprehensive regulatory strategies for cell and gene therapy products.
  2. Manage the preparation, review, and submission of regulatory documents to health authorities.
  3. Serve as the primary point of contact with global regulatory agencies.
  4. Collaborate with cross-functional teams to ensure coordinated efforts across the product lifecycle.
Requirements
  • Bachelor's degree in life sciences or a related field (required).
  • Advanced degree (MS, PhD, PharmD) in a relevant field (preferred).
  • A minimum of 4-8 years of regulatory affairs experience in the biopharmaceutical industry.


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