Regulatory Affairs Expert, Chemistry and Manufacturing

6 uur geleden

Leiden, Zuid-Holland, Nederland Astellas Voltijd
About Us

Astellas is a forward-thinking healthcare partner delivering value and outcomes where needed. Our focus lies in innovative science, initially targeting areas of greatest potential, and subsequently developing solutions for patients with high unmet needs, often in rare or underserved disease areas and life-threatening conditions.

We work closely with patients, doctors, and healthcare professionals to ensure that patient and clinical needs guide our development activities at every stage. Patient Centricity is a guiding principle for action, and we believe all staff have a role to play in creating a patient-centric culture and integrating the patient perspective into our daily working practices.

We collaborate with regulatory authorities and payers to find new ways to ensure access to innovative therapies. We provide the latest insights and real-world evidence to inform decisions for patients and their caregivers, ensuring our medicines continue to deliver meaningful outcomes.

Job Summary

This Regulatory Lead position plays a key role in global leadership, overseeing multiple regulatory activities in collaboration with stakeholders, including RA functions, Pharmaceutical Technology, Quality Assurance, and Business Partners. Key responsibilities include developing global CMC regulatory strategies, driving global CMC RA-related activities, and successfully executing regulatory strategies with stakeholders.

Key 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.
Essential Knowledge & Experience
  • Experience with global regulatory aspects of CMC across multiple dosage forms involving undefined frameworks with technical complexity and broad scope.
  • Experience with process development, analytical characterization, process scale-up, and/or regulatory registration of drug substances or drug products (including oral and parenteral dosage forms) is required.
  • Ability to manage complex projects by exercising independent decision-making and analytical thinking skills.
  • Knowledge/experience of EU, US, and/or Japan regulations, guidelines, and regulatory processes for NCEs, NBEs, and product life cycle maintenance.
Estimated Salary

£80,000 - £110,000 per annum, depending on experience and qualifications.

About the Role

This permanent, full-time position is based in the United Kingdom or the Netherlands. The role follows our hybrid working model, requiring a blend of home and office work with a minimum of 1 day per week in the office. Candidates must be located within a commutable distance of the office.

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