Regulatory Intelligence and Policy Lead, Director

At Astellas we are a progressive health partner, delivering value and outcomes where needed. We pursue innovative science, focusing 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 a Regulatory Intelligence and Policy Lead, you will lead the identification, interpretation, and communication of global CMC regulatory intelligence and emerging trends. Your insights will guide decision‑making across development, manufacturing, quality, and regulatory functions, ensuring organisational readiness in an evolving global regulatory landscape.

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 Responsibilities:

• Monitor and analyse worldwide regulations and trends (e.g., ICH, FDA, EMA, PMDA), providing timely insights and impact assessments to internal stakeholders.
• Develop and implement research strategic roadmaps aligned with corporate strategic plans (CSP).
• Translate complex regulatory changes into clear, actionable guidance for cross‑functional partners, including CMC development, manufacturing, quality, supply chain, and regional regulatory teams.
• Represent Astellas in industry working groups and regulatory dialogues.
• Build strong, strategic relationships with regulatory authorities, trade associations, and key opinion leaders to promote harmonised, science‑driven regulatory approaches.
• Advise senior leadership on CMC regulatory intelligence and contribute to major policy initiatives.
• Anticipate regulatory changes and ensure proactive preparation across the product lifecycle, supporting compliance, operational adaptation, and long‑term strategic planning.

Essential Knowledge & Experience:

• Experience in CMC Regulatory Affairs or related technical areas, with proven expertise in global regulatory frameworks.
• Proven expertise in global regulatory frameworks, regulatory intelligence, and external policy advocacy.
• Strong leadership, influencing, and communication capabilities across global, cross‑functional teams.
• Demonstrated ability to synthesize complex scientific/regulatory information into strategic recommendations.

Preferred Skills & Knowledge:

• Experience collaborating with trade associations and regulatory authorities.

Education:

• Health Science diploma or equivalent.

Additional information:

• Type of role: This is a permanent role.
• Location: UK, Netherlands or Ireland. This role follows a hybrid working model, blending home-based work with a minimum of 1 day per quarter in the office (to be confirmed based on primary location and business need). Flexibility may be required in line with business needs.

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.

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