Director or Senior Director, Regulatory Affairs
Kymera Therapeutics
August 29, 2026
Remote friendly (Greater Boston)
United States
Corporate Functions
How you’ll make an impact:
- Serves as the regulatory representative on study-level cross-functional teams, providing regulatory guidance and ensuring alignment with program objectives.
- Independently leads compilation, authoring, and completion of regulatory submission packages, driving submissions from initiation through filing (initial CTAs and INDs, plus amendments).
- Provides oversight and maintains partnership with CRO regulatory groups supporting assigned programs.
- Reviews regulatory packages as part of the drug release process.
- Drafts and generates designation requests and regulatory applications (e.g., Orphan Drug, Fast Track, Breakthrough Therapy) for assigned programs.
- Supports planning, preparation, and execution of health authority interactions (FDA meetings, scientific advice procedures, and other agency engagements), including briefing documents, meeting requests, responses to regulatory questions, and other regulatory communications.
- Evaluates regulatory precedent, guidance, and competitive intelligence to inform regulatory recommendations and development planning (development pathways, expedited programs, pediatric requirements, and regional filing considerations).
- Maintains awareness of the external regulatory environment (new guidance, legislation, precedents) and disseminates insights to cross-functional stakeholders.
- Contributes to defining and implementing standard processes and best practices for the regulatory group.
Skills and experience you’ll bring:
- Minimum 5–7 years of drug development regulatory affairs experience, with progression.
- Independent experience managing/overseeing regulatory submissions (INDs/CTAs, amendments, designation requests).
- Strong knowledge of drug development processes and US regulatory requirements; global regulatory familiarity a plus.
- Knowledge of EU CTR and experience with CTIS submission processes.
- Excellent written/verbal communication; clear, concise writing and effective presentation to cross-functional teams.
- Strong critical thinking, prioritization, and problem-solving; self-starter managing multiple priorities.
- Collaborative team player across internal and external counterparts.
Compensation:
- Anticipated base salary range: $145,000–$215,000; eligibility for annual bonus, equity participation, and comprehensive benefits.
- Serves as the regulatory representative on study-level cross-functional teams, providing regulatory guidance and ensuring alignment with program objectives.
- Independently leads compilation, authoring, and completion of regulatory submission packages, driving submissions from initiation through filing (initial CTAs and INDs, plus amendments).
- Provides oversight and maintains partnership with CRO regulatory groups supporting assigned programs.
- Reviews regulatory packages as part of the drug release process.
- Drafts and generates designation requests and regulatory applications (e.g., Orphan Drug, Fast Track, Breakthrough Therapy) for assigned programs.
- Supports planning, preparation, and execution of health authority interactions (FDA meetings, scientific advice procedures, and other agency engagements), including briefing documents, meeting requests, responses to regulatory questions, and other regulatory communications.
- Evaluates regulatory precedent, guidance, and competitive intelligence to inform regulatory recommendations and development planning (development pathways, expedited programs, pediatric requirements, and regional filing considerations).
- Maintains awareness of the external regulatory environment (new guidance, legislation, precedents) and disseminates insights to cross-functional stakeholders.
- Contributes to defining and implementing standard processes and best practices for the regulatory group.
Skills and experience you’ll bring:
- Minimum 5–7 years of drug development regulatory affairs experience, with progression.
- Independent experience managing/overseeing regulatory submissions (INDs/CTAs, amendments, designation requests).
- Strong knowledge of drug development processes and US regulatory requirements; global regulatory familiarity a plus.
- Knowledge of EU CTR and experience with CTIS submission processes.
- Excellent written/verbal communication; clear, concise writing and effective presentation to cross-functional teams.
- Strong critical thinking, prioritization, and problem-solving; self-starter managing multiple priorities.
- Collaborative team player across internal and external counterparts.
Compensation:
- Anticipated base salary range: $145,000–$215,000; eligibility for annual bonus, equity participation, and comprehensive benefits.