What are the responsibilities and job description for the Associate Director or Director, Regulatory Affairs position at Kymera Therapeutics?

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.

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 contribute :

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, advanced degree preferred but not required.

8-10 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.

This position is based in Watertown, MA, and offers a hybrid work model with a minimum of 3 days / week in the office.

Skills and experience not an exact match? :

Go ahead and submit your resume (and a cover letter, if you'd like!). If this role isn't right for you, we can keep you in mind for future opportunities.

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.

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Associate Director or Director, Regulatory Affairs

What are the responsibilities and job description for the Associate Director or Director, Regulatory Affairs position at Kymera Therapeutics?

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Job openings at Kymera Therapeutics

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