Senior Manager, Regulatory Affairs
Kymera Therapeutics
August 08, 2026
Remote friendly (Greater Boston)
United States
Corporate Functions
How you’ll make an impact:
- Serve as the regulatory representative on study-level cross-functional teams, providing regulatory guidance and ensuring alignment with program objectives.
- Independently lead the compilation, authoring, and completion of regulatory submission packages, driving submissions from initiation through filing (including initial CTAs/INDs and amendments).
- Provide oversight and maintain partnership with CRO regulatory groups supporting assigned programs.
- Review regulatory packages as part of the drug release process.
- Draft and generate designation requests and regulatory applications (e.g., Orphan Drug, Fast Track, Breakthrough Therapy).
- Support planning, preparation, and execution of health authority interactions (including FDA meetings and scientific advice); contribute to briefing documents, meeting requests, responses to regulatory questions, and other regulatory communications.
- Evaluate regulatory precedent/guidance and competitive intelligence to inform regulatory recommendations and development planning (expedited programs, pediatric requirements, regional filing considerations).
- Maintain awareness of the external regulatory environment (new guidance, legislation, precedents) and disseminate insights to cross-functional stakeholders.
- Contribute to defining and implementing standard processes and best practices for the regulatory group.
Skills and experience you’ll bring:
- 5–7+ years of drug development regulatory affairs experience with progression.
- Experience independently managing/overseeing regulatory submissions (INDs/CTAs, amendments, designation requests).
- Strong knowledge of drug development processes and US regulatory requirements; global regulatory exposure a plus.
- Knowledge of EU CTR and experience with CTIS submission processes.
- Excellent written and verbal communication; ability to present clearly to cross-functional teams.
- Strong critical thinking, prioritization, and problem-solving; self-starter in a fast-paced environment.
- Collaborative team player across internal and external partners.
Compensation:
- Anticipated base salary range: $145,000–$215,000; eligibility for annual bonus, equity participation, and comprehensive benefits.
- Serve as the regulatory representative on study-level cross-functional teams, providing regulatory guidance and ensuring alignment with program objectives.
- Independently lead the compilation, authoring, and completion of regulatory submission packages, driving submissions from initiation through filing (including initial CTAs/INDs and amendments).
- Provide oversight and maintain partnership with CRO regulatory groups supporting assigned programs.
- Review regulatory packages as part of the drug release process.
- Draft and generate designation requests and regulatory applications (e.g., Orphan Drug, Fast Track, Breakthrough Therapy).
- Support planning, preparation, and execution of health authority interactions (including FDA meetings and scientific advice); contribute to briefing documents, meeting requests, responses to regulatory questions, and other regulatory communications.
- Evaluate regulatory precedent/guidance and competitive intelligence to inform regulatory recommendations and development planning (expedited programs, pediatric requirements, regional filing considerations).
- Maintain awareness of the external regulatory environment (new guidance, legislation, precedents) and disseminate insights to cross-functional stakeholders.
- Contribute to defining and implementing standard processes and best practices for the regulatory group.
Skills and experience you’ll bring:
- 5–7+ years of drug development regulatory affairs experience with progression.
- Experience independently managing/overseeing regulatory submissions (INDs/CTAs, amendments, designation requests).
- Strong knowledge of drug development processes and US regulatory requirements; global regulatory exposure a plus.
- Knowledge of EU CTR and experience with CTIS submission processes.
- Excellent written and verbal communication; ability to present clearly to cross-functional teams.
- Strong critical thinking, prioritization, and problem-solving; self-starter in a fast-paced environment.
- Collaborative team player across internal and external partners.
Compensation:
- Anticipated base salary range: $145,000–$215,000; eligibility for annual bonus, equity participation, and comprehensive benefits.