Lead, Regulatory Affairs Chemistry, Manufacturing, and Controls
Join to apply for the Lead, Regulatory Affairs Chemistry, Manufacturing, and Controls role at Astellas Pharma
Lead, Regulatory Affairs Chemistry, Manufacturing, and Controls
12 hours ago Be among the first 25 applicants
Join to apply for the Lead, Regulatory Affairs Chemistry, Manufacturing, and Controls role at Astellas Pharma
Description
Lead, Regulatory Affairs Chemistry, Manufacturing, and Controls
About Astellas
At Astellas we are making treatments that matter to people.
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.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Legal
* Industries
Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Astellas Pharma by 2x
Get notified about new Regulatory Affairs Specialist jobs in Addlestone, England, United Kingdom.
Crawley, England, United Kingdom 2 weeks ago
Greater London, England, United Kingdom 2 weeks ago
Slough, England, United Kingdom 1 week ago
London, England, United Kingdom 1 week ago
Regulatory Affairs Specialist (Orthopaedic Reconstruction)
London, England, United Kingdom 1 week ago
Greater London, England, United Kingdom 1 week ago
Quality Assurance and Regulatory Affairs Associate
Uxbridge, England, United Kingdom 3 weeks ago
Maidenhead, England, United Kingdom 1 day ago
Maidenhead, England, United Kingdom 7 hours ago
London, England, United Kingdom 1 month ago
London, England, United Kingdom 1 week ago
Regulatory Affairs Specialist - Software
Crawley, England, United Kingdom 1 day ago
London, England, United Kingdom 1 day ago
Regulatory Affairs & Stewardship Specialist
London, England, United Kingdom 1 week ago
Senior Scientific and Regulatory Affairs Associate – Contaminants & Packaging
Slough, England, United Kingdom 2 days ago
Senior Specialist, European Country Regulatory Affairs
London, England, United Kingdom 1 day ago
Associate General Counsel, Competition & Regulatory
London, England, United Kingdom 6 days ago
Regulatory Science Specialist - £73,324 p.a. + benefits
London, England, United Kingdom 2 weeks ago
Regulatory Affairs and Quality Assurance (RAQA) Manager
London, England, United Kingdom 2 months ago
Regulatory Affairs Lead - Studentjob.co.uk
London, England, United Kingdom 7 hours ago
Global Regulatory Affairs Manager (Global Program Regulatory Manager)
London, England, United Kingdom 1 week ago
Slough, England, United Kingdom 2 weeks ago
Regulatory Specialist - Studentjob.co.uk
Eton, England, United Kingdom 7 hours ago
International Regulatory Affairs Associate Director (Senior International Program Regulatory Manager)
London, England, United Kingdom 1 week ago
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr