Regulatory Affairs Leader in Global Chemistry and Manufacturing

7 dagen geleden


Leiden, Zuid-Holland, Nederland Astellas Voltijd

Astellas is a pioneering health partner committed to delivering value and outcomes where needed. Our global vision for Patient Centricity emphasizes understanding the patient experience to support innovative health solutions.

The Opportunity

We are seeking a seasoned Regulatory Affairs Leader to play a key role in our global leadership team. As the CMC Regulatory Lead, you will be responsible for multiple regulatory activities, collaborating with stakeholders to develop global CMC regulatory strategies and drive RA-related activities.

  • Serve as the CMC regulatory lead or Deputy for complex projects/products and participate in related activities.
  • 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.
  • Ensure timely compilation and submission of global documents, reviewing for consistency and quality across regions, including eCTD Module 3 documents.

This is a permanent, full-time position based in the United Kingdom or the Netherlands. We follow a hybrid working model, requiring a blend of home and at least one day per week in the office. The estimated salary for this position is around £90,000 - £120,000 per annum, depending on experience and qualifications.



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