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Regulatory Affairs Associate

Job LocationCambridge
EducationNot Mentioned
Salary£25.00 - £32.00 per hour
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

We are currently looking for a Regulatory Affairs Associate to work on a 12 month contract for a industry leading biotech company.Due to the big elephant in the room known as Brexit, there will be new GB licenses for existing products, and as such our client is looking for someone with experience covering the UK & Ireland to offer support around submissions for national variations to the MHRA.We are therefore looking to speak with any candidates with a minimum of 1 years’ experience working on submissions for UK&I.Responsibilities include:

  • Ensure regulatory submissions are made on time and meet Amgen’s corporate and local regulatory requirements.
  • Contribute to and execute the filing plan for their country where applicable
  • Review promotion and non-promotion materials
  • Maintain an awareness of & ensure local management are kept up to date on new & developing local legislation & regulatory policy
  • Disseminate relevant information to team(s) as appropriate
  • Participate in local regulatory process improvements initiatives
  • Assist locally in Healthcare Compliance activities where applicable
  • Coordinating and reviewing briefing documents and/or other submissions for meetings with Regulatory agencies.
  • Collate, distribute, exchange and archive regulatory information with regulatory colleagues and cross functional teams and provide advice on local regulatory considerations in a timely manner.
  • Basic qualifications:
  • Relevant Bachelor’s degree is essential
  • Experience in/knowledge of developing and maintaining CTA documentation in the EU (e.g. IMPDs, IMPD amendments) and ability to work with some autonomy
  • Knowledge and awareness of the relevant regulatory guidelines and legislation
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