Regulatory Affairs Officer

• £40k - 45k per year

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 shard 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 e.smailes@x4lifesciences to learn more about the role or connect with me on LinkedIn to hear about regular job updates available with X4 Life Sciences.