Senior Manager, Chemistry, Manufacturing & Controls, Regulatory Affairs

Senior Manager, Chemistry, Manufacturing & Controls, Regulatory Affairs

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.

About this role:

As the Senior Manager, CMC Regulatory Affairs, you will lead the Chemistry, Manufacturing, and Controls (CMC) aspects of regulatory activities. Collaborating closely with the CMCRA Global Lead and the Global Regulatory Lead, you will develop and execute CMC regulatory strategy, focusing on New Molecular Entities (NMEs). Your role involves crafting essential CMC documents (e.g., CMC modules, IND/IMPD CMC documentation) for assigned products and serving as the subject matter expert (SME) for Regulatory CMC. Working in tandem with stakeholders such as Pharmaceutical Technology and Manufacturing, Quality Assurance, and Business Partners, you will ensure seamless coordination and alignment. Your contributions will be instrumental in maintaining regulatory compliance and achieving strategic objectives.

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:

• Lead or act as Deputy for CMC regulatory aspects of complex projects/products, demonstrating autonomy and expertise.
• Prepare and review CMC documentation for assigned products, including e-CTD Quality modules, IND/CTA/IB, and briefing documents for Health Authority consultation meetings with minimal supervision.
• Function as the CMC regulatory expert for global project and product teams, contributing to and recommending global CMC regulatory strategy in collaboration with Astellas global Regulatory Affairs and other stakeholders.
• Ensure CMC compliance with applicable EMA/FDA/PMDA/ICH/Global regulations, actively participating in global project teams/task forces to interpret and apply regulatory requirements.
• Define and implement regulatory strategies and priorities for global and regional registrations, supplemental submissions/variations, response documents to health authority questions, and global change control processes. Actively contribute to strategic planning in therapeutic areas and impact global strategy for chemistry, manufacturing, and controls aspects.

Essential Knowledge & Experience:

• Extensive industry experience; pharma, CRO or academic with experience directly in Regulatory Affairs or in CMC Regulatory Affairs or role with CMC regulatory submission responsibilities in CMC related laboratories.
• Experience with global regulatory aspects of CMC across multiple dosage forms involving undefined frameworks with technical complexity and broad scope.
• Process development knowledge, analytical characterization, process scale-up and/or regulatory registration of drug substances or drug products (including oral or parenteral dosage forms) is required.
• Demonstrated track record for successful interactions with (global) health authorities related to CMC submissions.
• Effective writing skills with the ability to meet regulatory requirements and standards and ability to understand regulatory environment and apply concepts to perform job function.
• Fluent written and spoken English is required.

Preferred Experience:

• Experience in product development in the manufacturing or regulatory field.
• Advanced, interpersonal written and oral communication skills and advanced collaborative skills with an ability to work both reactively and proactively in a timely manner in a dynamic fast-paced environment.
• Able 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 and product life cycle maintenance.

Required qualification:

• BS in Chemistry/Pharmaceutics/Engineering or equivalent degree.

Additional information:

• This is a permanent, full-time position.
• Position is based in the Netherlands.
• This position follows our hybrid working model. Role requires a blend of home and a minimum of 2-3 days per week in our Leiden 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.