Global Regulatory CMC Director — Strategy & Submissions

Nuvation Bio, Inc.; New York (NY); Hybrid; USD 180,000 - 280,000; Full time

Benefits offered by this job

Equity plans

Unlimited vacation

Medical coverage

401K with company matching

Job summary

Nuvation Bio, Inc. is seeking a Director of Regulatory CMC to lead the strategic development and execution of global CMC regulatory strategies across the portfolio from discovery through post-approval.

You will manage regulatory submissions, ensure compliance with global health authority requirements, and liaison with technical operations, quality, and development teams. The role requires advanced degree and extensive experience in regulatory CMC, with responsibility for INDs, CTAs, NDAs, and

Qualifications

• Advanced degree in chemistry, pharmaceutical sciences, chemical engineering, or related field.
• Demonstrated ability to lead preparation, review, and delivery of CMC content for global regulatory submissions.
• Strong experience with global regulatory requirements (ICH, FDA, EMA, NMPA, MFDS).

Responsibilities

• Lead global Regulatory CMC strategies for clinical-stage and commercial products.
• Prepare, review, and deliver CMC sections and regulatory reports for submissions.
• Coordinate with CMOs, CDMOs, and external vendors to finalize CMC documentation.

Skills

Advanced degree

Regulatory CMC

Global submissions

Cross-functional collaboration

Education

Advanced degree in chemistry/pharmaceuticals

Job description

Nuvation Bio, Inc. is seeking a Director of Regulatory CMC to lead the strategic development and execution of global CMC regulatory strategies across the portfolio from discovery through post-approval.

You will manage regulatory submissions, ensure compliance with global health authority requirements, and liaison with technical operations, quality, and development teams. The role requires advanced degree and extensive experience in regulatory CMC, with responsibility for INDs, CTAs, NDAs, and