Kymera Therapeutics

Senior Manager, Regulatory Affairs

Watertown, MA · Senior

Sponsorship not specified$145k-$215kDetected 16 days ago

FDA RegulatoryCommunicationProblem SolvingCritical ThinkingRegulatory Affairs

About the role

Kymera is deploying TPD to address disease targets and pathways inaccessible with conventional therapeutics.
For more information about our science, pipeline and people, please visit www.kymeratx.com or follow us on X (formerly Twitter) or LinkedIn.
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.

Responsibilities

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.
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.
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.
Strong critical thinking, prioritization, and problem-solving skills; self-starter able to manage multiple priorities in a fast-paced environment.

Nice to have

Strong working knowledge of drug development processes and US regulatory requirements
familiarity with global regulatory frameworks a plus.

Skills

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.

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.

Benefits

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.

Company info

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.
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.
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.
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.

Equal 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.

Visa & Work Authorization

veteran status, pregnancy, sex, marital status, gender expression or identity, genetic information, sexual orientation, citizenship, or any other legally protected class

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This listing is sourced directly from Kymera Therapeutics's careers page and normalized into a canonical job model.