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Regulatory Affairs Specialist

1 week ago


hertfordshire, United Kingdom X4 Life Sciences Full time
Job Description

Job Title: Regulatory Affairs Officer

Salary: £40,000 - £45,000

Location: Hertfordshire, UK

Job Type: Permanent


A growing Pharmaceutical manufacturer are looking to expand their Regulatory team with the addition of a Regulatory Affairs Specialist. They are looking for an individual that is hard working and self- motivated to assist with all things regulatory.


Key Responsibilities:


  • Oversee all aspects of the lifecycle maintenance for registered Marketing Authorizations (MAs)
  • Assist in the preparation, compilation, and publication of documentation for the Common Technical Document (CTD) dossier.
  • Collaborate with in-house teams, third-party designers, and contract sites to develop and update packaging artwork.
  • Create and maintain patient information leaflets and packaging components, managing artwork to ensure compliance with regulatory standards and company approval systems.
  • Lead and/or assist in submitting licenses and authorizations for new products and modifications to existing products.


Experience and Qualifications Required:

  • Bachelors degree required, ideally in sciences, engineering, medical/scientific writing, or public health administration.
  • At least 2 years of experience in Regulatory Affairs or a related field.
  • Proven experience in preparing technical documentation for regulatory submissions.
  • Ability to work independently and manage daily regulatory responsibilities for a product portfolio.


How to apply: Apply to to learn more about the role or connect with me on LinkedIn to hear about regular job updates available with X4 Life Sciences.