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

Senior Manager, Regulatory Affairs – Leading Biopharma

Job Summary:

Excellent role in a leading biopharma company. Responsibility through the full regulatory cycle (development/registrations/post approval) working with high value, first in class products. Applicants are expected to have proven experience leading EU programmes including; Strategy, Agency Interactions, US liaison, but also be comfortable with day to day regulatory submission work.

Top company to work for with a great pipeline and ample opportunities for candidates to develop and grow. Market leading salary and package.

The Role:

Reporting into the TA Regulatory Director this position will play a pivotal role in driving regulatory development, registration activities and oversee maintenance of high value approved products. Responsibilities include but not limited to;

  • Oversee all regulatory activities for assigned products through the full regulatory lifecycle.
  • Key point of contact in health authority interactions – Scientific Advice, Agency Questions, etc.
  • Management of two more junior team members.
  • Assist in defining EU regulatory strategies and represent EU regulatory affairs at internal meetings 

Background

  • Minimum Requirement BSc. Advanced degree preferred
  • Proven experience in EU Regulatory Affairs – Including agency interaction
  • Line management experience preferred (not essential)

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

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

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