Director or Senior Director, Regulatory CMC
Kymera Therapeutics
August 21, 2026
Remote friendly (Greater Boston)
United States
Corporate Functions
How you’ll make an impact:
- Lead the development and execution of global regulatory CMC strategies for degrader programs across all stages, with emphasis on late-stage activities.
- Serve as regulatory CMC lead for multiple programs, partnering with CMC, Quality, Non-Clinical, and Clinical Development to align regulatory strategy with timelines.
- Author, review, and approve CMC content for regulatory submissions (INDs/CTAs, briefing documents, NDA/MAA modules, annual reports, amendments/supplements).
- Provide strategic regulatory CMC guidance to senior leadership on 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 guidance/requirements and advise cross-functional teams on impact and implementation.
- Provide regulatory oversight of CDMOs and external manufacturing/testing partners to ensure 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/PhD in Chemistry, Pharmaceutics, Biochemistry, Chemical Engineering, or related field.
- 10+ years progressive Regulatory Affairs CMC experience in biotechnology/pharma.
- Deep late-stage regulatory CMC experience (pivotal through NDA/MAA and post-approval).
- Extensive hands-on small molecule CMC experience (drug substance/product, control strategy, lifecycle management).
- Proven ability to independently manage/author CMC for small molecule INDs/CTAs and NDA/MAA; hands-on health authority interaction experience.
- Strong knowledge of global CMC requirements (FDA, EMA, ICH, other regions).
- Experience with analytical method development/validation, specification setting, post-approval change management.
- Excellent written/verbal communication; ability to translate technical info into regulatory strategy.
- Ability to lead cross-functionally and influence without direct authority; strong org/project management skills.
Compensation:
- Anticipated base salary range: $195,000–$330,000; eligibility for annual bonus, equity, and comprehensive benefits.
- Lead the development and execution of global regulatory CMC strategies for degrader programs across all stages, with emphasis on late-stage activities.
- Serve as regulatory CMC lead for multiple programs, partnering with CMC, Quality, Non-Clinical, and Clinical Development to align regulatory strategy with timelines.
- Author, review, and approve CMC content for regulatory submissions (INDs/CTAs, briefing documents, NDA/MAA modules, annual reports, amendments/supplements).
- Provide strategic regulatory CMC guidance to senior leadership on 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 guidance/requirements and advise cross-functional teams on impact and implementation.
- Provide regulatory oversight of CDMOs and external manufacturing/testing partners to ensure 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/PhD in Chemistry, Pharmaceutics, Biochemistry, Chemical Engineering, or related field.
- 10+ years progressive Regulatory Affairs CMC experience in biotechnology/pharma.
- Deep late-stage regulatory CMC experience (pivotal through NDA/MAA and post-approval).
- Extensive hands-on small molecule CMC experience (drug substance/product, control strategy, lifecycle management).
- Proven ability to independently manage/author CMC for small molecule INDs/CTAs and NDA/MAA; hands-on health authority interaction experience.
- Strong knowledge of global CMC requirements (FDA, EMA, ICH, other regions).
- Experience with analytical method development/validation, specification setting, post-approval change management.
- Excellent written/verbal communication; ability to translate technical info into regulatory strategy.
- Ability to lead cross-functionally and influence without direct authority; strong org/project management skills.
Compensation:
- Anticipated base salary range: $195,000–$330,000; eligibility for annual bonus, equity, and comprehensive benefits.