Regulatory Affairs Officer

6 days ago

Edinburgh, United Kingdom SRG Full time

SRG is working with a leading Biotechnology company based in the Edinburgh area who are looking for a Regulatory Affairs officer to join their team on a permanent basis.


The regulatory affairs officer is responsible for building regulatory strategy, determine applicable regulatory requirements, propose solutions to comply with regulatory requirements and manage product license registration with the appropriate regulatory authorities worldwide.


The Role:

  • Prepare and compile regulatory documentation, coordinate and execute regulatory submission for countries including US, EU, Canada and any other territories as appropriate in compliance with relevant regulations.
  • Develop product labelling regulatory requirements for products and for customer contracted products including but not limited to package labels, product labels and instructions for use.
  • Liaise with internal and external parties as required to support development of product labelling.
  • Contribute to the regulatory watch process by maintaining knowledge of new or update regulatory requirements, guidance documents and industry standards.
  • Ensure maintenance of product regulatory documents and technical files (including US, EU, Japan, Brazil, Canada) to ensure ongoing compliance.
  • Liaise with regulatory authorities and external contract bodies and, in response to requests from these, to collate and interpret specialised information.
  • Assist with the implementation of the Company’s Quality Policy.
  • Contribute to the design and implementation of regulatory processes and identify areas for potential improvement.


Requirements:

  • Scientific degree
  • Previous regulatory experience within Medical Devices / IVD is preferred but pharmaceutical regulatory experience will be considered.
  • Experience of working within an FDA licensed manufacturing facility.
  • Experience in meeting with and negotiating with regulators.


Benefits:

  • Private Medical cover
  • Life assurance
  • Additional annual leave
  • Cycle to work scheme + more.

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