Regulatory Lead, Regulatory Affairs, Chemistry, Manufacturing & Controls

About Astellas:

At Astellas we are a progressive health partner, delivering value and outcomes where needed. 

We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions. 

We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage. 

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 work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes. 

Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care. 

The Opportunity:

As the Regulatory Lead you will be responsible for a key global leadership role in the Regulatory Affairs department for the Chemistry, Manufacturing and Controls (CMC) aspects of regulatory documents and submissions. Moreover, you will be responsible for multiple regulatory activities in collaboration with stakeholders (e.g., other RA functions, Technology & Manufacturing, Quality Assurance, Business Partners). 

Furthermore, you will be responsible for developing global CMC regulatory strategy (e.g., CMC strategy/planning for NMEs), driving global CMC RA related activities and successfully executing regulatory strategies in collaboration with stakeholders. You will also be supporting business critical interactions inside and outside of Astellas Regulatory Affairs on complex CMC issues and questions in collaboration with local and global stakeholders.

Hybrid Working:

At Astellas, we recognize that our employees enjoy having a 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.

Key Activities for this role:

• Acts as a CMC regulatory lead/expert for global projects, ensuring compliance with EMA/FDA/ICH/global regulations.
• Manages preparation and review of global registration packages, ensuring effective data presentation and regulatory compliance.
• Defines and implements regulatory strategies for global registrations, variations, and health authority responses.
• Oversees global submissions, ensuring timely compilation and compliance with established standards and SOPs.
• Provides CMC regulatory expertise in new product planning, licensing, and due diligence activities.
• Interacts with global health authorities and stakeholders, influencing strategy and facilitating agency meetings.

Essential Knowledge & Experience:

• Extensive experience in CMC regulatory affairs with a proven track record of successful health authority interactions.
• Strong knowledge of global regulatory aspects for CMC across multiple dosage forms (oral and parenteral).
• Experience in process development, analytical characterization, and regulatory registration of drug substances/products.
• Advanced communication and collaboration skills, with the ability to manage complex projects and work cross-functionally.
• In-depth understanding of EU, US, and/or Japan regulatory processes for NCEs, NBEs, and product life cycle maintenance.

Preferred Qualifications:

• M.S. or Ph.D. in Chemistry/Biochemistry, PharmD, or equivalent degree with relevant experience in CMC regulatory or regulatory submission responsibilities.
• Experience in managing direct reports is preferred.

Education:

• Bachelor’s degree in chemistry or a related field such as HR, Data Science, Finance, or equivalent.

Additional information:

• This is a permanent, full-time position.
• This position is based in the United Kingdom.
• Fluent in written and spoken business English.
• This position follows our hybrid working model. Role requires a blend of home and a minimum of 2 days per week in the United Kingdom office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office.

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.