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.

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

Please refer the Job description for details