Senior Manager Regulatory

Description:

Barinthus Biotherapeutics is on a quest for a Senior Manager or Manager of Regulatory Affairs Strategy who is not just looking for a job, but a calling. With us, you’ll embark on a journey of discovery, guiding the immune system to conquer chronic diseases, autoimmunity, and cancer.

What You’ll Be Doing
 

• Strategize for Success: Provide input to the global regulatory strategy to support clinical trials and registration of our cutting-edge immunotherapeutic products.
• Drive Regulatory Excellence: Work with experts to create strategic regulatory submissions to regulatory agencies world-wide.
• Collaborate for Impact: Align regulatory strategies with product development plans, working with diverse teams to dig deep into the data to create novel registration strategies.
   

Essential Skills And Requirements
 

• Biologics Regulation Expertise: Experience in the regulation of biologics, including immunomodulating therapies and vaccines, is highly valued.
• Product Development Insight: In-depth experience with clinical and non-clinical regulatory aspects of products in development.
• Global Regulatory Knowledge: Strong experience with biologics registration requirements in Europe/UK and familiarity with international regulations (US FDA).
• Regulatory Lifecycle Proficiency: Solid understanding of Regulatory Life Cycle Management and eCTD format for regulatory filings.
• Submission Mastery: Demonstrated ability in drafting and organizing regulatory submissions, amendments, and supplements.