Regulatory Affairs Manager OTC

4 weeks ago


Maidenhead, Windsor and Maidenhead, United Kingdom Hays Specialist Recruitment Limited Full time
Regulatory Affairs Manager OTC Job Description

This well-established Consumer Health company is seeking an experienced Regulatory Affairs Manager / Senior Manager to join their team. The role is a 6-month contract with potential for extension.

Main Responsibilities:
  • Manage post-approval activities for specified OTC products.
  • Support the EMEA Regulatory Affairs team for post-approval activities for MRP/DCP products across EEA.
  • Coordinate worksharing procedures for CMC and non-CMC variation, when WS is appropriate.
  • Develop regulatory strategies, prepare regulatory applications, and support maintenance activities for MRP/DCP products.
  • Support the team with regulatory activities for European procedures (Decentralised, Mutual Recognition, WS) as appropriate.
Requirements:
  • Prior experience in preparing and compiling regulatory submissions (Variations, renewals, PSUSA etc.).
  • Responses to Regulatory Agency (RA) questions and other correspondence in accordance with EU regulations and guidelines for OTC, Consumer Health products.
What You'll Get:

Flexible working options are available.

For more information on this or any other Regulatory Affairs jobs within OTC, Consumer Health, Medical Devices, or Cosmetics, please apply to this advert and ask for Victoria Dunlop.



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