Regulatory Affairs Director
Vor 4 Tagen
Regulatory Affairs - CMC
**About the Role**
Advanced Resource Managers is seeking an experienced Regulatory Affairs Director to lead the development and execution of CMC regulatory strategies for biological products in the EMEA region. As a key member of our team, you will provide innovative solutions and strategic regulatory intelligence to drive product development from preclinical through registration and product optimization.
**Key Responsibilities**
* Serve as the subject matter expert on biologics, providing CMC regulatory guidance for the preparation of regulatory submissions to the EMA and regional agencies.
* Oversee the preparation, review, and submission of CMC sections (Module 3) specific to biological products, in regulatory filings such as MAA and variations.
* Lead the CMC regulatory management and submission planning of post-approval changes, including manufacturing process changes, site transfers, and formulation updates for biological products.
* Ensure continuous compliance with regulatory requirements throughout the lifecycle of the biological product, managing variations and renewals.
**What We Offer**
This is a permanent full-time position that offers a competitive salary and an extensive benefits package. If you are a motivated and experienced Regulatory Affairs professional looking for a new challenge, please submit your application.
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