Regulatory Lead in Chemistry, Manufacturing and Controls

1 week geleden


Leiden, Zuid-Holland, Nederland Astellas Voltijd
Astellas Regulatory Affairs: CMC Regulatory Lead Role

At Astellas, we are a progressive health partner delivering value and outcomes where needed. Our pursuit of innovative science focuses on areas of greatest potential, developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.

Key Responsibilities:
  • Play a key role in a global leadership position, driving global CMC RA-related activities and successfully executing regulatory strategies in collaboration with stakeholders.
  • Manage a small team or mentor one or more individuals, acting as a CMC regulatory expert for global project teams.
  • 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.
Requirements:
  • A strong background in Chemistry, Biochemistry, Engineering, or PharmD, with relevant experience in CMC regulatory or a role with CMC regulatory submission responsibilities.
  • Ability to manage complex projects, exercising independent decision making and analytical thinking skills.
  • Detail and goal-oriented, quality conscientious, and customer-focused, with excellent communication and teamwork skills.
  • Fluent in written and spoken business English.

Astellas is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.



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