• South East
  • Applications have closed
  • Salary: £40-45k

Senior Regulatory Officer – Leading Generics

Senior Regulatory Officer – Leading Generics

The Company

Excellent opportunity in a leading generics company with a truly global presence and one of the broadest portfolios of products across multiple therapy areas. Working in one of the company’s key global hubs this role would offer excellent training/development opportunities in a company that invests in its internal talent

The Role

Working in a leading global generic company this role would be responsible for all aspects of EU generic regulatory work. Reporting into the Regulatory Manager responsibilities would include, but not be limited to;

·      Initial MAA submission for generic Rx products to competent authorities through CP

·      Responsibility for the Compilation/Authoring/Review of CMC (module 3) documentation

·      Ongoing lifecycle maintenance of approved products; Variation, Renewals, Labelling changes

·      Act as a key point of contact with both internal and external stakeholders; MHRA, EMA

Background

·      Minimum Requirement BSc. Advanced degree preferred

·      Proven experience in EU generic Regulatory Affairs – including strong understanding of CMC

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, Officer, Associate, Senior Officer, Senior Associate, Regulatory Affairs, MAA, Generics, CMC

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