New · posted Oct 15
Kymera Therapeutics · Biotechnology
Director or Senior Director, Regulatory CMC
- Watertown, MA
- On-site
- Full-time
- Director
Open until filled
The role
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.
What you need
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.
Skills named in this posting
- Regulatory Affairs CMC (10+ years)
- Late-stage NDA/MAA and post-approval CMC
- Small molecule drug substance and drug product
- IND/CTA authoring
- FDA/EMA health authority interactions
- Global CMC regulatory guidance (ICH)
- Analytical method validation and specifications
- Cross-functional leadership and project management
What you'll do
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.
Pay and benefits
$195,000 – $330,000 a year
Employer provided- 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.
Annual bonus eligibility
Equity participation
Comprehensive benefits
Where you'll work
Watertown, MAOn-siteOpen in Maps (opens in a new tab)
More jobs in Watertown, MAFrom the posting
About Kymera Therapeutics
Kymera is a clinical-stage 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.
Equal opportunity, accessibility and legal noticesKymera Therapeutics's statements, word for word
Equal Employment Opportunity
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.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 25% above the US median for Regulatory CMC roles at this level.
This roleEmployer provided
Director roles in Massachusetts20 roles publishing pay
Director roles in the US43 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $195,000 | — | $330,000 |
| Massachusetts (middle half) | $199,625 | $222,500 | $244,125 |
| All US (middle half) | $190,500 | $210,000 | $244,500 |
This role: Kymera Therapeutics's own published range. Comparisons: the base pay employers published on open Regulatory CMC roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory CMC
The general path across 82 open Regulatory CMC roles on Regulatory Jobs, with the titles they carry most. Not Kymera Therapeutics's own promotion track.
Career resources on Regulatory CMC
Skills DNA
What this role leans on
How many of the posting's 21 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership10
- Regulatory submissions9
- Lab testing and methods2
- GMP and compliance1
- Documentation and SOPs1
- Validation and qualification1
- Regulatory Affairs CMC (10+ years)
- Late-stage NDA/MAA and post-approval CMC
- Small molecule drug substance and drug product
- IND/CTA authoring
- FDA/EMA health authority interactions
- Global CMC regulatory guidance (ICH)
- Analytical method validation and specifications
- Cross-functional leadership and project management
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- FDAFDA IND(official source, opens in a new tab)Investigational New Drug applications
- FDAFDA NDA(official source, opens in a new tab)New Drug Applications
Company hiring pulse
Kymera Therapeutics on Regulatory Jobs
- 2
- Open roles
- 2
- Distinct roles
- 1
- Locations
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Director or Senior Director, Regulatory CMC at Kymera Therapeutics
Open until filled. $195K–$330K a year, employer provided.