Director, Regulatory CMC – Small Molecule Biotech

Kymera Therapeutics; Massachusetts; On-site; USD 195,000 - 330,000; Full time

Benefits offered by this job

Annual bonus

Equity

Benefits

Job summary

Kymera Therapeutics is seeking a senior Regulatory Affairs CMC leader to drive global CMC strategies for degrader programs from early development through NDA/MAA submissions. You will collaborate with CMC, Quality, and Clinical teams to align regulatory plans with program timelines and ensure readiness for health authority interactions.

The role emphasizes hands-on CMC submissions experience for small molecule programs, lifecycle management, and cross-functional leadership in a fast-paced

Qualifications

• BS, MS, or PhD in Chemistry, Pharmaceutics, Biochemistry, Chemical Engineering, or a related scientific discipline.
• 10+ years of progressive Regulatory Affairs CMC experience in biotech/pharma.
• Experience in late-stage CMC activities and small molecule development.

Responsibilities

• Lead global regulatory CMC strategies for degrader programs across all stages, with emphasis on late-stage activities.
• Serve as regulatory CMC lead for multiple programs, coordinating with CMC, Quality, Non-Clinical and Clinical teams.
• Author, review, and approve CMC content for INDs/CTAs, NDA/MAA, and regulatory amendments.
• Provide strategic CMC guidance to senior leadership on health authority interactions and risk mitigation.
• Lead meetings and correspondence with FDA, EMA, and other authorities on CMC matters.
• Monitor evolving global CMC guidance and advise cross-functional teams on impact.
• Oversee CDMOs and external manufacturing partners to ensure submission readiness.
• Scale and lead Regulatory Affairs CMC as the pipeline grows.

Skills

CMC leadership

Regulatory strategy

Health authority

Cross-functional leadership

Lifecycle management

Regulatory submissions

Education

PhD/MS in related field

Job description

Kymera Therapeutics is seeking a senior Regulatory Affairs CMC leader to drive global CMC strategies for degrader programs from early development through NDA/MAA submissions. You will collaborate with CMC, Quality, and Clinical teams to align regulatory plans with program timelines and ensure readiness for health authority interactions.

The role emphasizes hands-on CMC submissions experience for small molecule programs, lifecycle management, and cross-functional leadership in a fast-paced