Head of Regulatory Affairs

3 weeks ago


Manchester, United Kingdom Blackfield Associates Full time

Blackfield are supporting a speciality pharmaceutical distribution company, based in Greater Manchester, hiring for a Senior Regulatory Affairs Manager. This is a great opportunity for an experienced Regulatory professional to step up into senior leadership.

As Head of Regulatory Affairs, you will:

  • Lead the Regulatory Affairs team
  • Oversight of license compliance with MHRA
  • Submit new MAA / licences variations to regulatory authority
  • Act as point of contact for the company with the MHRA, external stakeholders and licence users
  • Assist in the training and further development of junior RA team members
  • Managing approved suppliers for repackaging

To be considered for the role of Head of Regulatory Affairs, you will have:

  • Minimum 5 years experience in Regulatory Affairs, ideally gained in a generic, speciality or pharma distribution
  • Must have proven MHRA experience, including submissions and acting as point of contact/ lead meetings
  • Strong cGMP, gained within wholesale distribution or drug manufacturing
  • Previous line management/ leading a team
  • A strong communicator, looking to develop their career and be a leader

This is a permanent position, working hybrid from our clients Greater Manchester base. Minimum 3 days per week onsite.

Unable to sponsor, all applicants must hold valid Right to Work in the UK.



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