Global Regulatory CMC Expert Lead

1 week geleden


Leiden, Zuid-Holland, Nederland Astellas Voltijd

Astellas, a progressive health partner delivering value and outcomes, is seeking an experienced professional to join our team as a Global Regulatory CMC Expert Lead. This role plays a key part in driving the development of innovative health solutions through a deep understanding of the patient experience.

About Astellas

We pursue science where needed, focusing on areas of greatest potential and developing solutions for high-patient-need disease areas. Our global vision is to support the creation of patient-centric culture and integrate awareness of the patient into our working practices.

Job Description

The successful candidate will be responsible for managing complex projects, exercising independent decision-making and analytical thinking skills, and contributing to strategic planning in the therapeutic area. You will oversee the preparation and review of registration packages, collaborate with stakeholders to enhance submission quality, and ensure timely compilation and submission of documents.

Key responsibilities include:

  • Driving global CMC RA-related activities and executing regulatory strategies in collaboration with stakeholders
  • Supporting business-critical interactions inside and outside of Astellas Regulatory Affairs on complex CMC issues and questions
  • Managing small teams or mentoring individuals, acting as a CMC regulatory expert for global project teams

This is a permanent, full-time position based in the United Kingdom or the Netherlands, requiring a blend of home and at least one day per week in the Netherlands office. We offer a hybrid working solution allowing time to connect with colleagues in person alongside flexibility to work from home.

Requirements

To succeed in this role, you will need:

  • Fluent written and spoken business English
  • Degree in Chemistry/Biochemistry/Engineering, PharmD or equivalent degree
  • Relevant experience in CMC regulatory or roles with CMC regulatory submission responsibilities

A salary range of £80,000 - £110,000 per annum reflects the level of expertise required for this position, depending on your background and qualifications.



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