Global Regulatory CMC Strategy Lead

Nuvation Bio, Inc.; Northern (KY); Hybrid; USD 180,000 - 250,000; Full time

Benefits offered by this job

Bonus plan

Equity participation

Unlimited vacation

401K with company match

Comprehensive medical, dental, vision

Job summary

Nuvation Bio, Inc. seeks a Director of Regulatory CMC to steer global strategies for clinical and commercial programs. You will coordinate cross-functional teams to prepare and submit CMC sections for INDs, NDAs/MAAs, and post-approval changes, ensuring compliance with ICH, FDA, EMA, and other authorities.

Ideal candidates bring 10+ years in Regulatory CMC with a proven track record of delivering high-quality global submissions and leading complex programs in a fast-paced biopharma setting.

Qualifications

• 10+ years in pharmaceutical industry with Regulatory CMC experience.
• Experience leading global regulatory submissions across development to post-approval.
• Expert understanding of ICH, FDA/EMA/NMPA/MFDS requirements.

Responsibilities

• Lead global Regulatory CMC strategies for clinical-stage and commercial products and lifecycle management.
• Author, review, and assess CMC documents and reports for global filings.
• Provide Regulatory CMC leadership to cross-functional teams to align with global expectations.
• Deliver high-quality CMC sections for INDs, CTAs, NDAs/MAAs, variations, and annual reports.
• Evaluate changes to manufacturing, analytics, and packaging and define submission strategies.
• Oversee interactions with CMOs/CDMOs and external labs for regulatory submissions.

Skills

Regulatory strategy

Cross-functional leadership

Global submissions

Communication

Regulatory intelligence

Attention to detail

Strategic thinking

Influence & collaboration

Education

Advanced degree in chemistry/pharmaceutics/related

Job description

Nuvation Bio, Inc. seeks a Director of Regulatory CMC to steer global strategies for clinical and commercial programs. You will coordinate cross-functional teams to prepare and submit CMC sections for INDs, NDAs/MAAs, and post-approval changes, ensuring compliance with ICH, FDA, EMA, and other authorities.

Ideal candidates bring 10+ years in Regulatory CMC with a proven track record of delivering high-quality global submissions and leading complex programs in a fast-paced biopharma setting.