Director or Senior Director, Regulatory Affairs

Kymera TherapeuticsWatertown, Massachusetts, United States · Posted 2 months ago

Full-timeEst. 262,500 USD

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:

Act as the global regulatory strategy lead for Kymera’s IRF5 degrader program, developing and driving the overall program regulatory strategy across multiple immunology and inflammation (I/I) indications.
Ensure global regulatory strategies are effectively and efficiently implemented and maintained in line with evolving regulatory and business needs.
Lead program teams through major regulatory filings and interactions, including INDs, CTAs/IMPDs, briefing packages, and health authority meetings.
Serve as the primary regulatory partner on the IRF5 program team, working closely with Clinical, CMC, Nonclinical, Quality, and Commercial colleagues.
Provide sound, science-based, solution-oriented regulatory guidance and advice to cross-functional program teams through strategic and flexible application of experience and regulatory knowledge.
Clearly communicate regulatory risks, opportunities, and recommendations to program teams and senior leadership.
Manage and support junior regulatory team members, including coaching, mentoring, and professional development.
Track relevant regulatory intelligence data and interpret and disseminate findings to internal teams.
Monitor the development of emerging regulations and guidances and advise on their impact to programs or business operations.
Contribute to building scalable regulatory processes and best practices as the team and pipeline grow.

Skills and experience you’ll bring:

Bachelor’s degree in a scientific discipline required; advanced degree preferred but not required.
Director: 8–10 years of Regulatory Affairs experience. Senior Director: 10–12+ years of Regulatory Affairs experience.
Demonstrated success acting as a regulatory lead, including substantial contribution to at least one marketing application submission and approval
Demonstrated ability to drive cross-functional teams to deliver on critical program regulatory milestones.
Experience working in rheumatology, GI, and/or other immunology or inflammation-related disease indications strongly preferred.
Direct experience leading a regulatory program through mid- and late-stage development.
Experience and ability to lead teams to prepare for and conduct regulatory interactions and negotiations with health authorities (e.g., FDA, EMA).
Excellent understanding and knowledge of global drug development and regulatory principles and practices (FDA, EMA, ICH), with the motivation to continually learn and build on existing skills and knowledge base.
Demonstrated ability to lead teams, internal and external, through excellent interpersonal and communication skills.

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 $195,000 – $330,000, 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.

Kymera TherapeuticsWatertown, Massachusetts, United States

Est. 262,500 USD

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