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Director of Regulatory Affairs CMC

2 months ago

Oxfordshire, United Kingdom Gleeson Recruitment Group Full time

Job title: Director, Regulatory Affairs CMC


A clinical stage biotechnology company focused within Oncology are seeking a Director, Regulatory Affairs CMC to join their team. In this role, you will act as primary contact with external regulatory bodies, as required, to ensure appropriate input into regulatory strategy, gain rapid approval of submissions and resolve any regulatory issues.



Responsibilities:


  • Planning, preparation and internal review of CMC documentation for Clinical Trial Applications, IND submissions and amendments, marketing applications, supplements, variations and other communications with regulatory authorities.
  • Advise on global CTA submission strategy and provide regulatory guidance to company personnel throughout the research and development process.
  • Attend project team meetings and provide CMC-related regulatory guidance to other functional areas, including, but not limited to Manufacturing, Quality, and Commercial Operations.
  • Direct life cycle management for assigned assets on a global basis, including regulatory impact assessments and preparation of CMC documentation for variations and other post-marketing submissions.



Requirements:



  • Pharmaceutical/biotechnology industry experience with technical management experience. Regulatory Affairs experience with a focus on CMC documentation and CMC lifecycle management within the pharmaceutical or biotechnology industry is required.
  • Working knowledge of FDA and EMA CMC guidance documents and regulations as well as working knowledge of international (e.g., LATAM and APAC) CMC requirements for investigational and marketed products is required.
  • Direct experience in interfacing with relevant regulatory authorities (FDA, EMA, and PMDA).
  • A Life sciences Degree would be beneficial.



Salary and benefits:



A highly competitive salary and wider benefits scheme is on offer.


To apply for this position or hear further details then please contact Freddie Hill via Freddie.hill@pharma-partners.co.uk