Regulatory Affairs Professional
2 days ago
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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