Regulatory Affairs Professional
20 hours ago
We are seeking a talented Regulatory Affairs Professional to join our team at X4 Life Sciences. The successful candidate can expect a salary of $90,000 - $115,000 per annum, based on their qualifications and experience.
Key Responsibilities:
- This role involves overseeing all aspects of the lifecycle maintenance for registered Marketing Authorizations (MAs).
- The successful candidate will assist in preparing, compiling, and publishing documentation for the Common Technical Document (CTD) dossier.
- Implementing and communicating MA changes to relevant stakeholders is a critical component of this role.
- Collaboration with internal teams, external vendors, and contract sites is essential for developing and updating packaging artwork.
- The Regulatory Affairs Professional will create and maintain patient information leaflets and packaging components, managing artwork to ensure compliance with regulatory standards and company approval systems.
- Liaising with various departments, clients, and regulatory authorities is vital for effective communication.
- Maintaining regulatory files, databases, and document chronologies, and tracking changes in documents submitted to agencies or partners is another key responsibility.
- Supporting New Product Development and Lifecycle Management projects is also an essential part of this role.
- The Regulatory Affairs Professional will lead and/or assist in submitting licenses and authorizations for new products and modifications to existing products.
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Regulatory Affairs Expert
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