Quality Assurance Manager
2 days ago
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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