TMF Director - Regulatory Readiness & Process Lead
$195k - $275kKymera Therapeutics
Kymera Therapeutics is seeking an experienced professional to lead TMF management and drive compliance within clinical trials. The ideal candidate will have over 10 years in the biotech industry and a robust track record in TMF management, ensuring readiness for regulatory inspections. The role demands strong leadership, experience in strategic process improvements, and collaboration across Clinical Operations and regulatory teams. The position offers a competitive salary range of $195,000 – $275,000 with additional benefits. #J-18808-Ljbffr
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...diseases, among others. Our lead oligonucleotide... ...attract colleagues who are ready to join a high-energy,... ...experience within a Regulatory Writing department at... ..., growing team. The Director of Regulatory Writing... ...development of strong internal processes, be the key liaison...Work at office$275k - $315k
...Therapeutics is seeking a strategic and experienced Senior Director of Regulatory Affairs to lead and execute US regulatory strategy for our biologics... ...and internal quality and SOP requirements; maintain audit-ready regulatory documentation and inspection readiness....Full timeTemporary workWork at officeLocal area3 days per week$195k - $330k
...Kymera is focused on building an industry-leading pipeline of oral small molecule... ...the development and execution of global regulatory CMC strategies for degrader programs across... ...ensure regulatory compliance and submission readiness.Scale and lead the Regulatory Affairs CMC...$110k - $155k
...services.Job TitleOperational Readiness Manager - Project... ...Managerial role is responsible for leading a team and overseeing the execution... ...Readiness stage-gate processes and clearly articulate these... ...Life Sciences, Engineering, Regulatory or related discipline OR a combination...Full timeRemote workWork visa- ...for an associate or director-level subject matter... ...programs are inspection ready. Position... ...development or refinement. Lead initiatives, create process/ standards, and ensure... ...team members within Regulatory, Quality, Data... ...objectives. Develop TMF standards and oversight...Work at officeFlexible hours
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...developing and delivering category‑leading precision therapies to... ...fully. Job Summary The Director, Regulatory Strategy - Global Regulatory... ...viability, and filing readiness. Maintain appropriate trackers... ...provided during the offer process. Equal Employment Opportunity...Local areaFlexible hours2 days per week$154.4k - $242.55k
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