Director, Companion Diagnostics Regulatory Affairs

Merck & Co.; Basking Ridge (NJ); On-site; USD 184,000 - 276,000; Full time

Job summary

Daiichi Sankyo, Inc. is seeking a senior regulatory leader to drive global CDx/IVD regulatory strategy for oncology products.

You will guide development programs, craft submission plans, and align regulatory activities across regions to maximize patient access and data quality. Responsibilities include coordinating with regional teams, managing FDA/EMA interactions, and ensuring timely registrations of both therapeutic and diagnostic assets in major markets.

Qualifications

• Bachelor's Degree preferably in a scientific discipline required.
• Advanced degree (e.g., Masters, Pharm.D., Ph.D., MD preferred).
• 7+ years regulatory affairs experience in pharmaceutical industry.

Responsibilities

• Provide strategic and tactical regulatory guidance for CDx/IVD development and submissions across regions.
• Represent Global CDx Regulatory position in cross-functional teams and with external partners.
• Lead Health Authority interactions and develop regulatory strategies for EU/UK/Switzerland and US.
• Prepare pre-submission documents and respond to HA queries/feedback in a timely manner.
• Monitor global regulatory developments and share insights with the CDx team.

Skills

Global Regulatory Strategy

CDx/IVD Regulatory

Regulatory Submissions

Cross-functional Collaboration

Strategic Planning

Education

Bachelor's degree

Advanced degree (Masters/PhD/PharmD)

Job description

Daiichi Sankyo, Inc. is seeking a senior regulatory leader to drive global CDx/IVD regulatory strategy for oncology products.

You will guide development programs, craft submission plans, and align regulatory activities across regions to maximize patient access and data quality. Responsibilities include coordinating with regional teams, managing FDA/EMA interactions, and ensuring timely registrations of both therapeutic and diagnostic assets in major markets.