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Senior Manager of Regulatory Affairs

2 months ago

Oxford, United Kingdom WALKER COLE INTERNATIONAL LTD Full time

Walker Cole is seeking a Senior Manager of Regulatory Affairs to join a clinical-stage biopharmaceutical company based in the South of England. This position has become available for a European and UK Regulatory Lead to oversee regulatory strategy for immunotherapeutic products at all development stages. Key responsibilities include creating plans for clinical and non-clinical regulatory submissions that align with project goals and working with the Regulatory CMC and Operations teams to ensure plans are coordinated and implemented effectively.

Additional Responsibilities as a Senior Manager of Regulatory Affairs:

  • Oversee submissions like INDs, CTAs, and applications for special designations such as DSURs, MAA/BL/NDA.
  • Manage study-specific regulatory tasks and actively engage in cross-functional departmental team discussions related to protocols, ensuring comprehensive support for the execution of clinical trials on a global scale.
  • Stay at the cutting edge of regulatory standards, actively engaging with draft guidance to shape the future of compliance, and communicate the latest regulatory shifts to keep the team ahead of the curve.

Requirement for the Senior Manager of Regulatory Affairs position:

  • A Degree/Masters/Pharm D/PhD in a related field.
  • Extensive experience in the pharmaceutical industry, with a focus on regulatory affairs.
  • Familiarity with clinical and non-clinical regulatory aspects of product development.
  • Strong background in the regulation of biologics.