Manager or Senior Manager, Regulatory Operations

Manager or Senior Manager, Regulatory Operations Watertown, MA About the job 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: • Lead the preparation, formatting, publishing, and delivery of regulatory submissions (e.g., INDs and amendments, CTAs and amendments, safety reports, annual reports) in eCTD format. • Manage submission timelines and ensure all components are received, published and validated to meet quality standards and regulatory deadlines. • Provide training for and support the maintenance of regulatory systems and tools, including RIM systems (Veeva), document review systems (Please Review), and standardized document templates (Starting Point). • Develop and maintain QC processes and checklists for Regulatory Operations activities to ensure high quality outputs. • Provide formatting and QC checks against company Style Guides and standards to ensure consistency and high quality of finalized submission documents. • Provide report level pdf publishing support in adherence of the eCTD technical Conformance Guide • Interface and collaborate with Regulatory Strategy and Clinical Development teams to align on submission content, sequencing, and timing. • Supporting the Regulatory operations function in regulatory audits and inspections by providing timely access to submission records and publishing history. Skills and experience you’ll bring: • Bachelor’s degree in Life Sciences or a related field • 5+ years of Regulatory Operations experience in clinical-stage biotech or pharmaceutical environment • Excellent understanding of the CTD structure, and granularity • Experience with submission templates, content plans, style guides, and SOPs in compliance with company policies and current regulatory standards (FDA, EMA, ICH) • Familiarity with study data technical conformance guide and metadata tagging • Experience working with Veeva RIM and Submissions Archive • SME in document formatting in MS word (familiarity with Accenture Starting Point is a plus) • Experience supporting global submissions (e.g., CTAs, INDs, briefing books, DSURs) • Excellent attention to detail and organizational skills • Ability to thrive in a fast-paced, matrixed, and evolving biotech environment 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.