Director or Senior Director, Regulatory CMC

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 is a clinical-style biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients’ lives. Kymera is deploying TPD to address disease targets and pathways inaccessible with conventional therapeutics. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Founded in 2016, Kymera has been recognized as one of Boston’s top workplaces for the past several years. For more information about our science, pipeline and people, please visit www.kymeratx.com or follow us on X (formerly Twitter) or LinkedIn.

How we work:

• PIONEER: We are courageous, resilient and rigorous in our mission to improve patients’ lives through our revolutionary degrader medicines.
• COLLABORATE: We value trust + transparency from everyone. Our goals are shared, our decisions data-driven and our camaraderie genuine.
• BELONG: We recognize our differences, inviting curiosity and inclusivity, so that our people are valued, seen, and heard.

How you’ll make an impact:

• Lead the development and execution of global regulatory CMC strategies for degrader programs across all stages of development, from early-stage activities through late-stage development and approval with specific emphasis on late-stage activities.
• Serve as the regulatory CMC lead for multiple programs, partnering closely with CMC, Quality, Non-Clinical, and Clinical Development teams to align regulatory strategy with program timelines.
• Author, review, and approve CMC content for regulatory submissions, including INDs/CTAs, briefing documents, NDA/MAA modules, annual reports, and amendments/supplements.
• Provide strategic regulatory CMC guidance to senior leadership regarding health authority interactions, submission risk, and mitigation planning.
• Lead preparation for, and participate in, meetings and correspondence with FDA, EMA, and other global health authorities on CMC matters.
• Monitor, interpret, and communicate evolving global CMC regulatory guidance and requirements, advising cross-functional teams on impact and implementation.
• Collaborate with and provide regulatory oversight of CDMOs and other external manufacturing/testing partners to ensure regulatory compliance and submission readiness.
• Scale and lead the Regulatory Affairs CMC function as the pipeline and organization grow.

Skills and experience you’ll bring:

• BS, MS, or PhD in Chemistry, Pharmaceutics, Biochemistry, Chemical Engineering, or a related scientific discipline.
• 10+ years of progressive Regulatory Affairs CMC experience in the biotechnology or pharmaceutical industry.
• Deep experience in late-stage (pivotal trials through NDA/MAA and post-approval) regulatory CMC activities.
• Extensive hands-on small molecule CMC experience, including direct work on small molecule drug substance and drug product development, control strategy, and lifecycle management.
• Demonstrated success independently authoring, reviewing, and managing CMC content for small molecule INDs/CTAs and marketing applications (NDA/MAA), with hands-on experience preparing for and participating in health authority interactions.
• Strong working knowledge of global CMC regulatory requirements and guidance for small molecule products across the product lifecycle (FDA, EMA, ICH, and other regional health authorities).
• Experience with small molecule analytical method development/validation, specification setting, and post-approval change management.
• Excellent written and verbal communication skills, with the ability to translate complex technical and scientific information into clear, actionable regulatory strategy.
• Proven ability to lead cross-functionally and influence without direct authority in a fast-paced, matrixed drug development environment.
• Strong organizational and project management skills, with the ability to manage multiple programs and competing priorities simultaneously.

Kymera Therapeutics is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, creed, gender, national origin, age, disability, veteran status, pregnancy, sex, marital status, gender expression or identity, genetic information, sexual orientation, citizenship, or any other legally protected class.

Compensation

• Kymera offers a competitive compensation package that recognizes both results and capabilities through market-based, performance-driven pay.
• The anticipated base salary range for this role is $195,000 – $330,000, with eligibility for annual bonus, equity participation, and comprehensive benefits.
• Actual salary is based on a holistic evaluation of the specific role/level as well as each candidate’s depth of experience and the capabilities they bring to the position.