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Regulatory Affairs Manager

4 months ago

Portsmouth Hampshire, United Kingdom Blackfield Associates Full time

Our client, a leading independent pharmaceutical company who have a wide range of specialist medications and generics, have an opportunity for an experienced EU/ UK Regulatory team leader to join their team in Hampshire. Find out if this opportunity is a good fit by reading all of the information that follows below. As Regulatory Affairs manager, you will:

  • Leading a small team, handling the regulatory activity across a large portfolio of medicine and licences across therapy areas including Oncology, CNS, respiratory
  • 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 have the following:
  • Minimum of 5 years of Regulatory Affairs experience in a relevant pharma company
  • Educated to degree level in a relevant life science discipline
  • Must have previous line management experience - ideally 3 or more direct reports to meet criteria
  • Worked in a broad role, covering R&D projects and CMC knowledge- a project manager approach
  • Must be commercially astute, with regular interactions with regulators and external stakeholders
  • Must have proven experience with EU and UK regulations for Pharmaceutical products or Combination products.
  • Valid right to work in the UK.
Due to the nature of the team, this person will be required at the Hampshire office at least 2 times a week. Hybrid working.