Senior Manager, Regulatory Affairs

Who we are: 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 . 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. How you’ll make an impact: Kymera Therapeutics is seeking a Senior Manager, Regulatory Affairs to serve as a key regulatory contributor and emerging strategic leader across multiple drug development programs. Reporting to the Director of Regulatory Affairs, the Senior Manager will independently lead regulatory activities at the study level, acting as the regulatory representative on cross-functional teams while driving execution of program regulatory strategies. This is a high visibility, dynamic role for a highly motivated regulatory professional ready to take on increasing autonomy and ownership in a fast-growing biotech environment. Serves as the regulatory representative on study-level cross-functional teams, providing regulatory guidance and ensuring alignment with program objectives Independently leads the compilation, authoring, and completion of regulatory submission packages, driving submissions from initiation through filing, including for initial CTAs and INDs and 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 the planning, preparation, and execution of health authority interactions, including FDA meetings, scientific advice procedures, and other agency engagements; contributes to 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, including assessments related to development pathways, expedited programs, pediatric requirements, and regional filing considerations. Maintains current awareness of the external regulatory environment, including new guidance documents, legislation, and precedents relevant to Kymera’s therapeutic areas, and disseminates insights to cross-functional stakeholders. Contributes to defining and implementing standard processes and best practices for the Kymera regulatory group. Skills and experience you’ll bring: A minimum of 5–7 years of drug development experience in regulatory affairs, with demonstrated progression in roles and responsibilities. Demonstrated experience independently managing and overseeing regulatory submissions (INDs/CTAs, amendments, designation requests). Strong working knowledge of drug development processes and US regulatory requirements; familiarity with global regulatory frameworks a plus. Knowledge and understanding of EU CTR and ex…