Senior Manager, Regulatory Affairs

Kymera Therapeutics, Inc.; Watertown (MA); Hybrid; USD 145,000 - 215,000; Full time

Job summary

Kymera Therapeutics, a clinical-stage biotechnology company, seeks a Senior Manager, Regulatory Affairs to lead study-level regulatory activities and drive submissions from initiation to filing. You will collaborate across cross-functional teams and manage agency interactions with increasing autonomy in a fast-growing biotech setting.

This role reports to the Director of Regulatory Affairs and requires strong US regulatory knowledge, strategic thinking, and effective communication to support

Qualifications

• 5-7 years of drug development experience in regulatory affairs.
• Independently manages regulatory submissions (INDs/CTAs, amendments).
• Strong knowledge of US regulatory requirements; EU CTR/CTIS a plus.
• Excellent written and verbal communication for cross-functional teams.
• Strong critical thinking, prioritization, and problem-solving skills.
• Collaborative team player able to work within regulatory group and with external partners.

Responsibilities

• Serve as regulatory representative on study-level cross-functional teams.
• Lead compilation, authoring, and completion of regulatory submission packages (INDs/CTAs, amendments).
• Provide oversight with CRO regulatory groups.
• Review regulatory packages as part of drug release process.
• Draft designation requests (Orphan Drug, Fast Track, Breakthrough) for programs.
• Support health authority interactions and agency engagements; contribute to briefing documents.
• Evaluate regulatory precedents and guidance to inform development planning.
• Maintain awareness of external regulatory environment and share insights.
• Contribute to standard processes and best practices for Kymera's regulatory group.

Skills

Regulatory submissions

IND/CTA experience

FDA meetings

US regulatory knowledge

Cross-functional collaboration

Regulatory strategy

Education

Bachelor's degree in life sciences

Tools

Regulatory databases

Regulatory submissions software

Job description

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 experience with CTIS submission processes.
• Excellent verbal and written communication skills, with an ability to write clearly and concisely as well as present information and ideas effectively to cross functional teams.
• Strong critical thinking, prioritization, and problem-solving skills; self-starter able to manage multiple priorities in a fast-paced environment.
• Collaborative team player able to work efficiently within the regulatory group, cross-functionally, and with internal and external counterparts.

Equal Employment Opportunity

Kymera Therapeutics is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, creed, gender, national origin, age, disability, veteran status, pregnancy, sex, marital status, gender expression or identity, genetic information, sexual orientation, citizenship, or any other legally protected class.

Compensation

• Kymera offers a competitive compensation package that recognizes both results and capabilities through market-based, performance-driven pay.
• The anticipated base salary range for this role is $145,000 - $215,000, with eligibility for annual bonus, equity participation, and comprehensive benefits.
• Actual salary is based on a holistic evaluation of the specific role/level as well as each candidate’s depth of experience and the capabilities they bring to the position.