Associate Director, Regulatory Affairs International Liaisons
About Astellas
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com .
Are you driven to make a real difference in the lives of patients?
We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.
Location and Working Environment
- This position follows our hybrid working model. The role requires a blend of home and minimum 2 - 3 days per week in our local office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office.
- Type of role: Permanent contract.
- Location: UK office (Addlestone).
- Astellas’ Responsible Flexibility Guidelines Statement- At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.
Purpose & Scope
- In support of the growing pipeline, the RA Lead International Liaison develops and executes regulatory strategies, plans, and processes for assigned development compounds and commercial products across the International and Greater China region (MEAR, APAC, LATAM, mainland China, and Hong Kong).
- The role ensures strategies apply best in class scientific, therapeutic, and regulatory expertise and meet all regulatory and business requirements. It interprets and incorporates regulatory trends and policies to ensure programs reflect the most up to date approaches in each sub region.
- The RA Lead International Liaison collaborates with Global RA Leads and Regional functions to ensure full alignment on global and regional regulatory strategies.
- The role also facilitates the International RA Primary Focus strategy with commercial, business, and R&D leaders, supporting sustainable success with Health Authorities and influencing development and post registration processes across the regions.
Role and Responsibilities
- Liaise across RA functions with minimal guidance, fostering collaboration, trust, scientific and regulatory excellence, innovation, and proactive delivery aligned with Astellas objectives.
- Establish RA strategies to monitor the global regulatory environment and ensure trends and policies are interpreted, communicated, and implemented internally.
- Lead regulatory strategy input for International and Greater China regions, ensuring robust contributions (e.g., CMC RA, CCDS labeling) and expert review of major deliverables.
- Develop and execute regulatory processes that support timely project/product progression aligned with Astellas’ short and long term business goals.
- Oversee regional regulatory submissions and partner with sub regions to deliver high quality applications (Scientific Advice, IND, MAA, NDA, BLA, variations) meeting regulatory standards and SOPs.
- Collaborate and guide stakeholders across Commercial, Market Access, GRLs/RRLs/PMs, and Extended RA teams; stay current on regional regulatory policy; contribute to Health Authority and partner interaction strategies.
Required Qualifications
- Extensive pharma development & RA experience, with strong scientific and regulatory expertise and credibility with authorities.
- Ability to interpret complex technical information and apply evolving regulatory requirements across projects and programs.
- Deep knowledge of GMP, GLP, GCP, ICH and proven experience leading submissions, regulatory interactions, and approvals.
- Effective operation in global/regional environments with strong leadership, negotiation, analytical, and problem solving skills.
- Excellent communication and interpersonal abilities, able to resolve conflicts and influence regulatory authorities and stakeholders.
- Fluent in English.
Preferred Qualifications
- Experience leading in a multi-national environment.
- Experience in leading submissions in emerging and export markets based upon a global development plan.
What awaits you at Astellas?
- Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
- Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
- Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
- A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.
Our Organizational Values and Behaviors
- Impact
- Innovation
- Integrity
- One Astellas
- Accountability
- Courage
- Sense of Urgency
- Outcome Focus
Benefits
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help.
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