Regulatory Affairs Specialist

3 weeks ago


Edinburgh, Edinburgh, United Kingdom SRG Full time

Company Overview: SRG is a leading Biotechnology company based in Edinburgh, Scotland. We are seeking an experienced Regulatory Affairs Officer to join our team on a permanent basis.

Salary: £55,000 - £65,000 per annum depending on experience.

Job Description:

  • We are looking for a skilled Regulatory Affairs Officer to build regulatory strategy, determine applicable regulatory requirements, and propose solutions to comply with regulatory requirements.
  • The successful candidate will manage product license registration with the appropriate regulatory authorities worldwide, including US, EU, Canada, and other territories as required.
  • This role involves preparing and compiling regulatory documentation, coordinating and executing regulatory submissions, and developing product labelling regulatory requirements.
  • The ideal candidate will have previous regulatory experience within Medical Devices / IVD or pharmaceutical regulatory experience.

Required Skills and Qualifications:

  • Scientific degree
  • Experience of working within an FDA licensed manufacturing facility
  • Negotiation skills to meet with and negotiate with regulators

Benefits:

  • Private medical cover
  • Life assurance
  • Additional annual leave
  • Cycle to work scheme


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