Description
Lead, Regulatory Affairs Chemistry, Manufacturing, and Controls
About Astellas
At Astellas we are making treatments that matter to people.
We are tackling the toughest health challenges putting the patient at the heart of every move we make.
Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.
We have developed ground-breaking, innovative medicines in immunology, oncology and urology. Our medicines are extending and saving the lives of cancer patients, making transplantation possible and improving the quality of life for those living with conditions where needs are often overlooked.
We take a patient-focused approach, that allows us to convert brilliant early science into treatments and solutions that directly improve and save patients’ lives.
From lab to clinic to patient, we focus on the most promising science, empower the best talent to pursue it, and develop life-changing solutions alongside the best partners.
The Opportunity
This position plays a key role within Astellas’ Global Regulatory Affairs team, focusing on the Chemistry, Manufacturing, and Controls (CMC) aspects of regulatory documentation and strategy. As a Lead Regulatory Affairs CMC, you will drive the development and execution of global CMC regulatory strategies for new and existing products. This role collaborates closely with cross-functional partners in Pharmaceutical Technology, Quality Assurance, and Manufacturing to ensure compliance with global health authority expectations and to support the successful development, registration, and lifecycle management of innovative therapies.
Hybrid Working
At Astellas we recognise that our employees enjoy having balance between their professional and home lives. We are proud of our hybrid approach which empowers you to have flexibility on whether to work from home or in the office.
In This Role You Will
- Act as the global Regulatory CMC Lead or Deputy for complex product development and lifecycle programs.
- Author and review high-quality CMC documentation, including Module 3 (eCTD), IND/IMPD/CTA packages, and briefing materials.
- Collaborate with global and regional teams to define and execute CMC regulatory strategies.
- Represent Astellas in Health Authority interactions, contributing as a CMC subject matter expert.
- Provide CMC regulatory guidance in cross-functional teams, licensing due diligence, and product planning activities.
Essential Knowledge & Experience
- Familiarity with EU, US, and/or Japan regulatory pathways, including INDs, NDAs, IMPDs, MAAs, and variations.
- Experience with biologics, vaccines, cell/gene therapies, or medical devices.
- Proven track record of preparing and overseeing global regulatory submissions (initial filings, variations, responses to queries) with strategic data presentation.
- Experience in ensuring consistency and compliance in submissions across regions (EU, US, Japan), with attention to changing regulations and standards.
- Experience in regulatory CMC or product development within pharma, biotech, or CRO settings.
Preferred Experience
- Excellent written and verbal communication skills, with the ability to manage complex projects in a fast-paced, cross-functional environment.
- Knowing how to provide regulatory input on process development, scale-up, and analytical characterization for multiple dosage forms.
Education
- Bachelor's degree or equivalent.
Additional Information
- This is a permanent full-time position.
- This position follows our hybrid working model. Role requires a blend of home and minimum 1 days per quarter in our Addlestone office.
- Flexibility may be required in line with business need. Candidates must be located within a commutable distance of the office.
- Occasional travel may be required for collaboration with external partners or attendance at scientific meetings.
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.
