About Astellas:
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 caregivers, 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:
Join our Precision Medicine & Diagnostics team — driving the co-development of companion diagnostics and advancing diagnostic testing to guide patient selection across all stages of drug development.
As the Diagnostic Regulatory Strategy Lead, you’ll be the go-to expert on diagnostics, shaping and executing global regulatory strategies, ensuring compliance, and supporting drug/CDx submissions across therapeutic areas.
Reporting to the Head of Precision Medicine & Diagnostics, this role offers the chance to influence the future of precision medicine through strategic regulatory leadership.
Hybrid Working:
At Astellas we recognise 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 optimise 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.
Key Responsibilities:
- Developing and implementing global regulatory strategies for diagnostics (IVD/CDx) aligned with drug development timelines and objectives across early and late-stage programs.
- Providing expert guidance on diagnostic regulatory pathways, including IVDR (EU), FDA (IDE, 510(k), PMA), and other global frameworks (e.g., Japan, China), supporting clinical study execution and companion diagnostic development.
- Assessing regulatory risks and proposing mitigation strategies to support evolving clinical programs.
- Leading and supporting the preparation of diagnostic-related regulatory submissions including IVDR clinical performance study applications, SRDs, IDEs, and briefing documents for agency interactions.
- Advising on and reviewing regulatory content in INDs, CTAs, and BLAs/NDAs/MAAs involving diagnostic components.
- Coordinating with external diagnostic partners to align regulatory strategies for drug and diagnostic programs, ensuring compliance and timely submissions.
- Partnering with drug regulatory affairs, clinical teams, precision medicine, and external diagnostic developers and CROs to enable compliant diagnostic testing and companion diagnostic development.
- Monitoring and interpreting evolving global IVD and companion diagnostic regulations, while supporting internal training initiatives and SOP development to ensure ongoing compliance and alignment with regulatory requirements.
Required Qualifications:
- Proven experience in regulatory affairs in pharma with a focus on diagnostics (IVD/CDx).
- Proven track record working in pharma of successful submissions under IVDR and FDA diagnostic regulatory pathways for drug clinical studies and companion diagnostics.
- Experience working in pharma with diagnostic development in oncology and/or other precision medicine areas.
- Familiarity with working in matrixed environments and cross-functional teams.
- Excellent communication, project management and leadership skills.
Preferred Experience:
- Regulatory Affairs Certification (RAC) or equivalent credentials are a plus.
- Regulatory experience in both pre-market and post-market environments.
Education:
- Bachelor’s degree in a relevant scientific or technical discipline (e.g., Life Sciences, Pharmacy, Regulatory Affairs).
- Advanced degree is preferred or equivalent
Additional Information:
- The is a permanent full-time position based in the UK.
- This position follows our hybrid working model. Role requires a blend of home and minimum of 1 day a quarter in our Addlestone office. Flexibility may be required in line with business need. 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.
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