Global CMC Regulatory Strategy Lead

Freyr Solutions; Princeton (NJ); On-site; USD 140,000 - 190,000; Full time

Job summary

Freyr Solutions, a global Regulatory Affairs and Life Sciences consulting organization, seeks a Sr Manager, Global Regulatory Affairs Strategist CMC in Princeton, NJ with remote work option. You will lead global CMC strategies and liaise with FDA and Health Authorities to enable timely product approvals.

The role requires 6+ years in biotech/pharma, 4+ years in regulatory CMC, and strong leadership across cross-functional teams to drive regulatory success worldwide.

Qualifications

• Bachelor’s degree in a scientific discipline; advanced degree preferred.
• 6+ years of biotechnology/pharmaceutical industry experience.
• 4+ years of regulatory CMC experience, with biologics or PDT preferred.
• Extensive experience in global pharmaceutical/biotechnological drug development and knowledge of global regulatory CMC environment.
• Demonstrated experience authoring and managing components of regulatory submissions.
• Strong knowledge of global regulatory requirements and ability to lead FDA interactions.

Responsibilities

• Define, coordinate, and implement global CMC regulatory strategies for product development and lifecycle.
• Provide strategic guidance to global regulatory and manufacturing teams for CMC objectives.
• Liaise with the FDA and Health Authorities regarding CMC issues.
• Manage CMC regulatory strategy for regulatory documentation (BLAs, INDs, CTAs, MAAs, variations).
• Advise on regulatory strategies to align with business goals and product registrations.
• Develop timelines for regulatory submissions and identify risks with cross-functional teams.
• Create high-quality CMC documents within defined timelines.
• Participate in discussions and negotiations with regulatory authorities as required.

Skills

Global regulatory strategy

FDA interactions

Regulatory submissions

Cross-functional leadership

Strategic thinking

Communication & negotiation

Education

Bachelor's degree in science

Job description

Freyr Solutions, a global Regulatory Affairs and Life Sciences consulting organization, seeks a Sr Manager, Global Regulatory Affairs Strategist CMC in Princeton, NJ with remote work option. You will lead global CMC strategies and liaise with FDA and Health Authorities to enable timely product approvals.

The role requires 6+ years in biotech/pharma, 4+ years in regulatory CMC, and strong leadership across cross-functional teams to drive regulatory success worldwide.