• South East
  • Applications have closed
  • Salary: On Application

Associate Director / Director, Regulatory CMC – Biologics

Summary:

New opportunity in a leading biopharma company with an enviable portfolio of products across therapy areas and truly global presence. Sitting in the company’s CMC biologics group this position would play a key role in the organisation and lead regulatory activities through all stages of development, from phase I to post-approval management.

The Role:

Reporting into the Senior Director CMC and focussed with biologic products this is a very visible role that will play a key role in bringing new and novel therapeutics to market. Responsibilities will include, but not be limited to;

  • Design and implementation of product specific strategies, ensuring successful development of CMC packages to support RoW registrations and lifecycle management activities
  • Key point of contact in interactions with Global regulatory agencies
  • Partner with Key internal stakeholders to align strategy for various biologic CMC programmes
  • Co-ordinate CMC sections of dossier for submission to health authorities
  • Liaise with all relevant internal & external stakeholders to ensure the highest standards of CMC documentation are maintained
  • Potential for line management responsibility for the right candidate

Requirements:

  • BS/MS in relevant discipline
  • Proven track record in CMC with a focus in Biologic products
  • BLA/CTD experience ideally
  • Proven management skills (line management for director level candidates)
  • Excellent written and oral communication skills

Full information on this job is available upon application (see below). For more information on this or other Regulatory Affairs vacancies please contact Adam Griffin on; 0207 096 0362 OR forward an up to date CV to adam.griffin@pharmappoint.net

 

Keywords: Regulatory, Regulatory Affairs, Associate Director, Senior Manager, Regulatory Affairs, MAA, biopharma, pharmaceutical 

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