Lead, Regulatory Affairs

Lead, Regulatory Affairs, Chemistry, Manufacturing and 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 (RA), Chemistry, Manufacturing and Controls CMC, you will play a key role in a global leadership role. You will be responsible for multiple regulatory activities in collaboration with stakeholders (e.g., other RA functions, Pharmaceutical Technology, Quality Assurance, Business Partners). Moreover, 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. Furthermore, you will be responsible for 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 recognise the importance of balancing your work and home life, so we offer a hybrid working solution allowing time to connect with colleagues in person at the office alongside the flexibility to work from home; optimising the most productive work environment for you to succeed and deliver. Key Activities for this role:

• Serve as the CMC regulatory lead or Deputy for complex projects/products and participate in related activities.
• Manage a small team or mentor one or more individuals.
• Act as a CMC regulatory expert for global project teams, recommending CMC regulatory strategies and ensuring alignment with global and local stakeholders.
• Oversee the preparation and review of complex global registration packages, ensuring effective data presentation and compliance with regulatory requirements. Collaborate with stakeholders to enhance submission quality and prepare summary tables from research and manufacturing reports.
• Ensure timely compilation and submission of global documents, reviewing for consistency and quality across regions, including eCTD Module 3 documents.
• Stay informed on corporate/global strategy and regulatory positions, contributing to strategic planning in the therapeutic area and CMC aspects with global stakeholders.
  
  Experience with global regulatory aspects of CMC across multiple dosage forms involving undefined frameworks with technical complexity and broad scope.
• Experience with process development, analytical characterization, process scale-up and/or regulatory registration of drug substances or drug products (including oral and parenteral dosage forms) is required.
• Ability 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, NBEs and product life cycle maintenance
• Ability to work in cross-functional and international environment; detail- and goal-oriented, quality conscientious, and customer-focused.
• Demonstrated track record for successful Health Authority interactions related to CMC submissions.
• Fluent in written and spoken business English.
Preferred Knowledge & Experience:
• Combination product experience (US, EU, JP).
• M.S. or Ph.D in Chemistry/Biochemistry/Engineering, PharmD or equivalent degree and relevant experience in CMC regulatory or role with CMC regulatory submission responsibilities.
• Experience managing direct report is preferred.
• Additional experience beyond small molecules, such as biologics, vaccines, cell/gene therapy or medical devices might be a preference., BS in Chemistry or equivalent degree.
  
  At Astellas, we believe that nurturing exceptional relationships with our employees delivers exceptional results. We can offer an inspiring place to work and a chance to make your mark in doing good for others.
Our expertise, science and technology make us a pharma company. Our open and progressive culture is what makes us Astellas. It's a culture of doing good for others and contributing to a sustainable society. Delivering meaningful differences for patients is our driving force. We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners. Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus; ownership; results; openness and integrity. We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership. Our aspiration is to bring the best brains together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit. For more information about our current career opportunities and how you can make a difference please visit https://www.astellas.com/eu/careers


• This is a permanent, full-time position.
• This position is based in the United Kingdom or the Netherlands.
• This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per week in the Netherlands office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office.