Global Regulatory CMC Director - Strategy & Submissions

Nuvation Bio, Inc.; United States; Remote; USD 210,000 - 300,000; Full time

Benefits offered by this job

Salary + Equity

Unlimited vacation

Excellent benefits

401K with matching

Bonus program

Job summary

Nuvation Bio, Inc. is seeking a Director of Regulatory CMC to lead global strategies for drug substance and product, driving planning, execution, and lifecycle management of CMC submissions across INDs, CTAs, NDAs/MAAs, and post-approval activities.

You will coordinate with manufacturing, analytical science, quality, and clinical teams to ensure compliant submissions. The role requires deep regulatory expertise, strong leadership, and the ability to influence senior stakeholders and health

Qualifications

• Advanced degree in chemistry, pharmaceutical sciences, chemical engineering, or related field with 10+ years in pharma.
• Experience leading global Regulatory CMC strategy across clinical development to post-approval.

Responsibilities

• Lead global Regulatory CMC strategies for clinical-stage and commercial products.
• Author, review, and assess CMC documents and reports for filings.
• Provide Regulatory CMC leadership to cross-functional teams to meet global expectations.
• Oversee CMC sections for INDs, CTAs, IMPDs, NDAs/MAAs and variations.
• Manage interactions with CMOs/CDMOs and external labs for submissions.
• Monitor global Regulatory CMC trends and initiate improvement actions.

Skills

Regulatory CMC leadership

Global submissions

Cross-functional leadership

Strategic thinking

Regulatory communication

Education

Advanced degree in pharmacy/chemistry

Job description

Nuvation Bio, Inc. is seeking a Director of Regulatory CMC to lead global strategies for drug substance and product, driving planning, execution, and lifecycle management of CMC submissions across INDs, CTAs, NDAs/MAAs, and post-approval activities.

You will coordinate with manufacturing, analytical science, quality, and clinical teams to ensure compliant submissions. The role requires deep regulatory expertise, strong leadership, and the ability to influence senior stakeholders and health