Regulatory Affairs Strategist

4 days ago


Nottingham, Nottingham, United Kingdom Discover International Full time
Discover International: A Leading Biopharmaceutical Company

We are seeking an experienced Senior Manager Regulatory Affairs to join our team. This role will play a pivotal part in leading regulatory strategies and ensuring the successful approval and post-approval management of cutting-edge cell and gene therapy products.

With a strong background in regulatory affairs, you will collaborate closely with cross-functional teams to ensure compliance with global regulatory requirements, provide strategic regulatory guidance, and interact with regulatory agencies.

The ideal candidate will have a proven track record of leading regulatory submissions and obtaining approvals for advanced therapies. They will also have extensive experience interacting with major global health authorities.

Salary: $140,000 - $160,000 per year

About the Role
  • Develop and execute comprehensive regulatory strategies for cell and gene therapy products.
  • Manage the preparation, review, and submission of regulatory documents to health authorities.
  • Interact with regulatory agencies to facilitate product approvals.
  • Collaborate with cross-functional teams to align on regulatory strategies.
  • Stay current with evolving regulatory guidelines and communicate relevant updates to internal teams.
Requirements
  • Bachelor's degree in life sciences, biotechnology, or a related field.
  • Advanced degree (MS, PhD, PharmD) in a relevant field preferred.
  • Minimum 4-8 years of regulatory affairs experience in the biopharmaceutical industry.
Benefits
  • Opportunity to work with a leading biopharmaceutical company.
  • Competitive salary and benefits package.
  • Chance to lead regulatory submissions and obtain approvals for advanced therapies.


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