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Regulatory Affairs Director
vor 2 Monaten
Regulatory Affairs - CMC
**About the Role**
Advanced Resource Managers is seeking an experienced Associate Director to lead our client's regulatory affairs efforts in the EMEA region. As a key member of the team, you will be responsible for developing and executing CMC regulatory strategies for biological products.
**Key Responsibilities**
* Provide expert guidance on biologics regulatory requirements and develop strategic regulatory intelligence to support product development
* Lead the preparation, review, and submission of CMC sections (Module 3) for regulatory filings, including MAA and variations
* Oversee post-approval compliance and life cycle management, including manufacturing process changes, site transfers, and formulation updates
**Requirements**
* Strong knowledge of biologics regulatory requirements and experience in CMC regulatory affairs
* Excellent communication and leadership skills, with the ability to work effectively with cross-functional teams
* Ability to analyze complex regulatory information and develop strategic recommendations
**What We Offer**
* Competitive salary and benefits package
* Opportunity to work with a leading biotech business and contribute to the development of innovative products
**Contact Information**
Please submit your application through our website.
