Diagnostic Regulatory Strategy Lead

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians.  If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .

This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

Purpose and Scope :

The Precision Medicine and Diagnostics team is dedicated to the co-development of companion diagnostics and the implementation of diagnostic testing for patient selection and stratification in clinical studies across all phases of drug development.

As a Diagnostic Regulatory Strategy Lead, you will be the primary regulatory advisor on diagnostics, supporting drug development teams in developing and executing global regulatory strategies for diagnostics, including global diagnostic compliance for drug development and drug / CDx submissions across therapeutic areas. This position reports to the Head of Precision Medicine & Diagnostics.

Responsibilities and Accountabilities :

• Develop and implement global regulatory strategies for diagnostics (IVD / CDx) aligned with drug development timelines and objectives in early and late-stage drug programs.
• Provide expert guidance on diagnostic regulatory pathways including IVDR (EU), FDA (IDE, 510(k), PMA), and other global regulatory frameworks (e.g., Japan, China) for clinical study execution and companion diagnostic development.
• Assess risk of diagnostic regulatory strategies to support evolving clinical development and propose mitigations
• Lead and / or support preparation of diagnostic related regulatory submissions including IVDR clinical performance study applications, SRDs, IDEs, and briefing documents for agency meetings.
• Advise on and review regulatory content in INDs, CTAs, and BLAs / NDAs / MAAs where diagnostic components are involved.
• Coordinate with external diagnostic partners to align on regulatory strategies for drug and diagnostic to ensure regulatory compliance and timely submissions.
• Partner with drug regulatory affairs, clinical trials unit, clinical development, precision medicine teams, and external diagnostic developers and CROs to enable compliant diagnostic testing and companion diagnostic development.
• Support health authority interactions and participate in meetings if needed.
• Monitor and interpret evolving global IVD and companion diagnostic regulations.
• Support internal training and SOP development related to diagnostic regulatory requirements.