Regulatory Affairs Manager

3 weeks ago


England, United Kingdom Blackfield Associates Full time

Job Description

Our client, an independent pharmaceutical company who manufacture and specialising in generics, have an opportunity for an experienced EU/ UK Regulatory team leader to join their team in Hampshire.

As Regulatory Affairs manager, you will:

  • Leading a small team, handling the regulatory activity across a large portfolio of medicine and medical device/ combination products
  • Working with EU, UK, and RoW regulatory bodies; as the subject matter expert for Medicines; Medical Devices and related ISO activities (including ISO13485 and ISO14971); Controlled Drugs; Nutritional Products; In Vitro Diagnostic Devices; Biocidal Products
  • Review and support for submission of new product dossiers and technical files – both own development, in-licensed and out-licensed and all aspects of regulatory lifecycle maintenance for existing products
  • Author technical documentation, including EU eCTD dossier sections, technical file documents and product artwork, for alignment with applicable regulations and guidance and assessing suitability for submission where appropriate.
  • Regulatory Strategy and Scientific Writing
  • Finial signatory on artwork and labelling material

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

  • Minimum of 5 years of Regulatory Affairs experience in a relevant pharma environment
  • Educated to degree level in a relevant life science discipline
  • Previous line/people management experience
  • Well versed in Project Management/ larger portfolio
  • Must have proven experience with EU and UK regulations for medicinal products/ devices

Due to the nature of the team, this person will be required at the Hampshire office at least 3 times a week. Hybrid working.

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