Global Director, Companion Diagnostics Regulatory Strategy

Initial Therapeutics, Inc.; Basking Ridge (NJ); On-site; USD 184,000 - 276,000; Full time

Job summary

Daiichi Sankyo is seeking a leader to drive global regulatory strategy for biomarkers, companion diagnostics and related devices used with oncology products. You will guide regulatory pathways and resolve complex issues to accelerate access to patients.

Responsibilities include guiding CDx development and submissions across countries, serving as PoC for regulatory requirements, coordinating with Health Authorities, and contributing to strategic decisions and risk management.

Qualifications

• Bachelor's Degree preferably in a scientific discipline required.
• Advanced degree (e.g., Masters, Pharm.D., Ph.D., MD preferred).
• 7+ years relevant pharmaceutical experience including experience within Regulatory Affairs required.
• Extensive experience developing companion diagnostics and devices required.
• Experience of drug development and drug regulatory procedures.
• Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device Development and Commercialization process required.

Responsibilities

• CDx development: Provide critical strategic and tactical regulatory guidance for CDx/IVD development and submission planning across regions.
• CDx RA Strategy: Represent Global CDx Regulatory position within cross-functional teams and with external partners.
• Health Authority Submission Preparation: Assist with pre-submission documents and respond to regulatory queries.
• Collaborate with Dx partners to ensure robust assay development and participate in HA meetings.
• Keep abreast of evolving global regulatory environment for devices and share updates.

Skills

Regulatory strategy

CDx development

Global regulatory submissions

Education

Bachelor's Degree in scientific discipline

Advanced degree (Masters/PhD/MD)

Job description

Daiichi Sankyo is seeking a leader to drive global regulatory strategy for biomarkers, companion diagnostics and related devices used with oncology products. You will guide regulatory pathways and resolve complex issues to accelerate access to patients.

Responsibilities include guiding CDx development and submissions across countries, serving as PoC for regulatory requirements, coordinating with Health Authorities, and contributing to strategic decisions and risk management.