Quality Assurance Manager

2 days ago


Hertfordshire, United Kingdom X4 Life Sciences Full time

Regulatory Affairs Specialist Job Description:

X4 Life Sciences is seeking a highly motivated and experienced Regulatory Affairs Specialist to join our team. This role offers an exciting opportunity to work in a fast-paced and collaborative environment where you will be responsible for ensuring that our products comply with regulatory requirements.

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: £43,000 - £48,000 per annum, depending on experience



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