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Associate Director, Quality Assurance
7 days ago
We are recruiting an experienced Director, Regulatory CMC to join our team in Cork, Ireland.
In this role, you will be responsible for ensuring the quality and compliance of our biologics manufacturing processes and managing a team of regulatory CMC professionals.
Key responsibilities include:
- Collaborating with cross-functional teams to ensure regulatory submissions meet application regulations and guidance governing the development, licensure and marketing of drugs, biologics and/or gene therapy medicinal products
- Leading regulatory CMC support for impact assessment to change control, deviation and cGMP inspection readiness at the site
- Coordinating and tracking regulatory commitments related to drug substance and drug product technology transfers
Requirements:
- Bachelor's degree in a relevant field
- Minimum 8 years of experience in Regulatory Affairs, CMC
- Strong leadership and management skills
