Regulatory Affairs Professional

2 days ago


Hertfordshire, United Kingdom X4 Life Sciences Full time

About the Role:

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at X4 Life Sciences. As a key member of our Regulatory team, you will be responsible for overseeing all aspects of the lifecycle maintenance for registered Marketing Authorizations (MAs).

The ideal candidate will have a strong background in Regulatory Affairs, with experience in preparing technical documentation for regulatory submissions. You will work closely with in-house teams and external partners to develop and update packaging artwork, create patient information leaflets, and manage artwork to ensure compliance with regulatory standards.

Key Responsibilities:

  • Oversee lifecycle maintenance for registered MAs
  • Assist in preparation, compilation, and publication of CTD dossier documentation
  • Collaborate with in-house teams and third-party designers to develop and update packaging artwork
  • Create and maintain patient information leaflets and packaging components
  • Lead or assist in submitting licenses and authorizations for new products and modifications to existing products

Requirements:

  • Bachelor's degree 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

Salary Range: £40,000 - £45,000 per annum, depending on experience



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