Regulatory Affairs Specialist

1 month ago


Maidenhead, Windsor and Maidenhead, United Kingdom Fortrea Full time

Fortrea, a leading global contract research organization, is seeking a skilled Regulatory Affairs Specialist to support the preparation and submission of key documentation to regulatory authorities for new clinical trials. The ideal candidate will have a strong understanding of regulatory guidelines and legislation related to drug and biologic products.

Key Responsibilities:
  • Assist in preparing study documentation, including completion of necessary forms and regulatory materials.
  • Complete and review the Medicines Information Form, with particular attention to Section D9, for IRAS/Combined Review submissions.
  • Prepare amendments and submit routine documents to regulatory authorities and REC/HRA.
  • Coordinate the collection and organization of data required by regulatory authorities.
  • Participate in client and team meetings and liaise with clients regarding regulatory submission matters.
Requirements:
  • Bachelor's Degree in Life Sciences or equivalent field.
  • Minimum of 2 years of experience in the pharmaceutical industry, preferably in Regulatory Affairs or Drug Development.

Fortrea is committed to delivering high-quality clinical trials and is seeking a motivated and detail-oriented Regulatory Affairs Specialist to join our team.



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