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Director or Senior Director, Regulatory Affairs

Kymera Therapeutics
Posted 3 months ago, valid for 9 days
Location

Watertown, MA 02472, US

Salary

$145,000 - $215,000 per year

Contract type

Full Time

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Sonic Summary

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  • Kymera Therapeutics is seeking a Senior Manager of Regulatory Affairs with 5-7 years of drug development experience in regulatory affairs.
  • The role involves independently leading regulatory activities for multiple drug development programs and serving as a regulatory representative on cross-functional teams.
  • Candidates should possess a strong working knowledge of drug development processes and US regulatory requirements, with experience in immunology or gastroenterology preferred.
  • The anticipated base salary for this position ranges from $145,000 to $215,000, along with eligibility for an annual bonus and equity participation.
  • Kymera is committed to creating a diverse and inclusive workplace and considers all applicants without regard to legally protected characteristics.

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 one or more assigned programs, including developing and driving overall program regulatory strategy, managing and overseeing all regulatory submissions, and acting as the Kymera point of contact with US FDA and other global health authorities.
  • Provides sound, science-based, solution-oriented regulatory guidance and advice to cross functional program teams through strategic and flexible application of experience and regulatory knowledge.
  • Leads and manages program teams through major regulatory filings and interactions.
  • Tracks relevant regulatory intelligence data and interprets and disseminates to internal teams.
  • Conducts external regulatory due diligence.
  • Monitors the development of emerging regulations and guidance’s and advises on impacts to programs or business operations.
  • Manages and supports junior regulatory team members.

 

Skills and experience you’ll bring:

  • Bachelor’s degree in a scientific discipline and 8+ years of Regulatory Affairs experience.
  • Experience acting as a regulatory program lead with the ability to drive cross functional teams to deliver on critical program regulatory milestones.
  • Experience working in dermatology, respiratory, rheumatology and/or other immunological related disease indications.
  • Direct experience leading a broad range of regulatory submissions from early to late-stage development.
  • Experience and ability to lead teams to prepare for and conduct regulatory interactions and negotiations.
  • Excellent understanding and knowledge of global drug development and regulatory principles and practices 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.

 

 




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