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Regulatory Affairs Specialist
1 week ago
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.