Senior Manager, Regulatory Affairs
Kymera Therapeutics
June 25, 2026
Remote friendly (Greater Boston)
United States
Corporate Functions
How you’ll make an impact:
- Serve as regulatory representative on study-level cross-functional teams; provide regulatory guidance and ensure alignment with program objectives.
- Independently lead compilation, authoring, and completion of regulatory submission packages; drive submissions from initiation through filing (including initial CTAs/INDs and amendments).
- Provide oversight and maintain partnership with CRO regulatory groups for 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 (FDA meetings, scientific advice procedures, and other agency engagements); contribute to briefing documents, meeting requests, responses to regulatory questions, and regulatory communications.
- Evaluate regulatory precedent/guidance/competitive intelligence to inform regulatory recommendations and development planning (expedited programs, pediatric requirements, regional filing considerations).
- Maintain awareness of the external regulatory environment and disseminate insights to 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 regulatory affairs experience in drug development, with progression.
- Experience independently managing regulatory submissions (INDs/CTAs, amendments, designation requests).
- Experience representing Regulatory Affairs on cross-functional study teams.
- Bachelor’s degree in a scientific discipline (advanced degree preferred).
- Strong knowledge of US regulatory requirements (global frameworks a plus).
- Knowledge of EU CTR and CTIS submissions.
- Ideally experience in immunology or gastroenterology.
- Excellent written/verbal communication; strong critical thinking/prioritization/problem-solving; self-starter; collaborative.
Compensation (as stated): anticipated base salary $145,000–$215,000; eligibility for annual bonus, equity participation, and comprehensive benefits.
- Serve as regulatory representative on study-level cross-functional teams; provide regulatory guidance and ensure alignment with program objectives.
- Independently lead compilation, authoring, and completion of regulatory submission packages; drive submissions from initiation through filing (including initial CTAs/INDs and amendments).
- Provide oversight and maintain partnership with CRO regulatory groups for 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 (FDA meetings, scientific advice procedures, and other agency engagements); contribute to briefing documents, meeting requests, responses to regulatory questions, and regulatory communications.
- Evaluate regulatory precedent/guidance/competitive intelligence to inform regulatory recommendations and development planning (expedited programs, pediatric requirements, regional filing considerations).
- Maintain awareness of the external regulatory environment and disseminate insights to 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 regulatory affairs experience in drug development, with progression.
- Experience independently managing regulatory submissions (INDs/CTAs, amendments, designation requests).
- Experience representing Regulatory Affairs on cross-functional study teams.
- Bachelor’s degree in a scientific discipline (advanced degree preferred).
- Strong knowledge of US regulatory requirements (global frameworks a plus).
- Knowledge of EU CTR and CTIS submissions.
- Ideally experience in immunology or gastroenterology.
- Excellent written/verbal communication; strong critical thinking/prioritization/problem-solving; self-starter; collaborative.
Compensation (as stated): anticipated base salary $145,000–$215,000; eligibility for annual bonus, equity participation, and comprehensive benefits.