Manager, Regulatory Affairs
<h3>Who we are:</h3>
<p>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.</p>
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<h3>How we work:</h3>
<ul>
<li><strong>PIONEER</strong>: We are courageous, resilient and rigorous in our mission to improve patients’ lives through our revolutionary degrader medicines.</li>
<li><strong>COLLABORATE</strong>: We value trust + transparency from everyone. Our goals are shared, our decisions data-driven and our camaraderie genuine.</li>
<li><strong>BELONG</strong>: We recognize our differences, inviting curiosity and inclusivity, so that our people are valued, seen, and heard.</li>
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<h3>How you’ll contribute:</h3>
<ul>
<li>In close collaboration with the regulatory program leads, provide regulatory support and guidance to multiple drug development programs.</li>
<li>Represent Regulatory Affairs on study level and program cross-functional teams, collaborating to develop global regulatory submission strategies to support CMC, nonclinical and clinical activities to achieve program milestones.</li>
<li>Responsible for planning, developing, and managing submissions for assigned programs, including but not limited to, Initial INDs, IND amendments, CTAs, safety reports, Annual Reports, DSURs etc.</li>
<li>Manages CROs responsible for Ex-US clinical trial regulatory submissions.</li>
<li>Supports regulatory lead in developing and implementing long and short-term product regulatory strategies</li>
<li>Supports the planning and execution of health authority meetings.</li>
<li>Monitors the development of emerging regulations and guidance and advises on impacts to programs or business operations.</li>
<li>Contributes to defining and implementing standard processes and best practices for the Kymera regulatory group.</li>
</ul>
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<h3>Skills and experience you’ll bring:</h3>
<ul>
<li>Bachelor’s degree in a scientific discipline, advanced degree preferred but not required.</li>
<li>A minimum of 3 years of experience in a Regulatory Affairs function at a biotech/pharma company.</li>
<li>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.</li>
<li>Demonstrated working knowledge of drug development processes and US regulatory requirements.</li>
<li>Knowledge and understanding of EU CTR and experience with CTIS submission processes.</li>
<li>Experience in small molecule mid to late-stage drug development.</li>
</ul>
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<p><strong><em>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</em></strong><strong> </strong><strong><em>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.</em></strong></p>
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