Global Regulatory CMC Strategy Director

Nuvation Bio; United States; On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Competitive Base Salary, Bonus, and Eq

Unlimited Vacation and 10 Sick Days

Excellent Medical, Dental, and Vision

401K with Company Matching

Job summary

Nuvation Bio seeks a Director of Regulatory CMC to lead global regulatory strategies across the portfolio, from discovery through post-approval. You will manage IND/CTA/MAA submissions and liaise with CMOs, CDMOs, and authorities to ensure compliant, inspection-ready filings.

The role requires an advanced degree and 10+ years in Regulatory CMC, with strong leadership and communication to guide diverse teams through complex regulatory challenges.

Qualifications

• Advanced degree in chemistry, pharmaceutical sciences, chemical engineering, or related discipline.
• 10+ years pharma industry experience with Regulatory CMC leadership.
• Experience leading global regulatory submissions across clinical, marketing, post-approval.
• Strong knowledge of ICH guidelines and FDA/EMA/NMPA/MFDS requirements.

Responsibilities

• Lead global Regulatory CMC strategies for clinical-stage and commercial products.
• Author, review, and assess CMC documents and reports for global filings.
• Provide Regulatory CMC leadership to cross-functional teams to align with regulatory expectations.
• Oversee CMC sections for INDs, CTAs, IMPDs, NDAs/MAAs, amendments, variations, and annual reports.
• Evaluate complex CMC changes and define global submission strategies.
• Lead CMC gap assessments and identify filing risks and remediation plans.
• Coordinate with CMOs/CDMOs and external consultants for regulatory submissions.
• Provide Regulatory CMC review of manufacturing, analytical, stability, and quality data.
• Lead CMC interactions with regulatory authorities and preparation of briefing materials.
• Ensure submission content is compliant with ICH/FDA/EMA and other authorities.

Skills

Regulatory CMC

Global regulatory strategy

Cross-functional leadership

IND/CTA/MAA submissions

Communication skills

Regulatory submissions

Education

Advanced degree in chemistry/pharmaceutical sciences or related

Tools

Module 3/CMC documentation

Regulatory submission management

Job description

Nuvation Bio seeks a Director of Regulatory CMC to lead global regulatory strategies across the portfolio, from discovery through post-approval. You will manage IND/CTA/MAA submissions and liaise with CMOs, CDMOs, and authorities to ensure compliant, inspection-ready filings.

The role requires an advanced degree and 10+ years in Regulatory CMC, with strong leadership and communication to guide diverse teams through complex regulatory challenges.