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Senior Regulatory Affairs Associate - Remote

WALKER COLE INTERNATIONAL LTD
Job LocationCambridge
EducationNot Mentioned
Salary40,000 - 55,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time Work from home

Job Description

Walker Cole International are looking for a Senior Regulatory Affairs Associate to join an exciting Biopharmaceutical company in the UK. In this role you will be responsible for the development and execution of regulatory submissions for the business projects.You will be responsible for:

  • The maintenance of regulatory files and databases including the Trial Master File.
  • The preparation, risk analysis and planning of submissions for assigned programs and projects.
  • Collaborate with both internal and external stakeholders to support the execution of regulatory submissions.
  • Maintaining oversight and working knowledge of relevant laws, guidelines and requirements.
  • Marketing Authorisation and Variation/Renewal applications.
A successful candidate will have:
  • A Bachelors degree in a scientific field.
  • An understanding of the drug product lifecycle from R&D through to marketing.
  • An understanding of pre-clinical and clinical drug development.
  • A working knowledge of FDA, EMA and ICH regulatory guidelines.
Regulatory Affairs | RA | Senior Regulatory Affairs Officer | GMP | Pharmaceutical | Regulatory | Submission | Product Dossiers | EU | Global | MHRA | FDA | Good Manufacturing Practice | CTD | Common Technical Documentation | Module 1 | Module 2 | Module3 | Module 4 | Module 5 | TMF | Trial Master File | Clinical | R&D

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