Regulatory Lead for Chemistry, Manufacturing and Controls
7 dagen geleden
Job Summary: We are seeking a Regulatory Lead for Chemistry, Manufacturing and Controls to play a key role in a global leadership role. As a CMC regulatory expert, you will drive global CMC RA-related activities and successfully execute regulatory strategies in collaboration with stakeholders. You will also be responsible for supporting business-critical interactions inside and outside of Astellas Regulatory Affairs on complex CMC issues and questions in collaboration with local and global stakeholders.
Key Responsibilities:
- Manage a small team or mentor one or more individuals.
- Act as a CMC regulatory expert for global project teams, recommending CMC regulatory strategies and ensuring alignment with global and local stakeholders.
- Oversee the preparation and review of complex global registration packages, ensuring effective data presentation and compliance with regulatory requirements.
- Collaborate with stakeholders to enhance submission quality and prepare summary tables from research and manufacturing reports.
- Ensure timely compilation and submission of global documents, reviewing for consistency and quality across regions, including eCTD Module 3 documents.
- Stay informed on corporate/global strategy and regulatory positions, contributing to strategic planning in the therapeutic area and CMC aspects with global stakeholders.
Requirements:
- PhD in Chemistry/Biochemistry/Engineering, PharmD or equivalent degree and relevant experience in CMC regulatory or role with CMC regulatory submission responsibilities.
- Experience managing direct report is preferred.
- Additional experience beyond small molecules, such as biologics, vaccines, cell/gene therapy or medical devices might be a preference.
About the Role: This is a permanent, full-time position. The role requires a blend of home and a minimum of 1 day per week in the Netherlands office. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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