Regulatory CMC Lead: Strategy & Submissions
Anagram Therapeutics, Inc.
Anagram Therapeutics, Inc. in Natick, MA is seeking an Associate Director to lead regulatory CMC activities across a broad portfolio for clinical and commercial programs. You will plan submission strategies, coordinate cross-functional teams, and ensure submissions meet health authority requirements. The role requires deep experience with regulatory CMC throughout the product lifecycle, INDs/NDA/BLA experience, and strong leadership. #J-18808-Ljbffr Anagram Therapeutics, Inc.
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$142.5k - $256.5k
The RoleThe Global Regulatory CMC Lead will be responsible for coordinating regulatory CMC activities... ...for developing global regulatory CMC strategies and collaborating with key... ...CMC regulatory strategies for global submissions (e.g. IND/CTA/BLA/MAA) and identify regulatory...RegulatoryPermanent employmentFull timeWork at officeWork from home$122.25k - $176.58k
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- ...is seeking an experienced Global Regulatory Affairs Lead to drive worldwide regulatory strategy for a late-stage/marketed... ...global regulatory strategy and submission planning across approved and pipeline... ...Partner with clinical, nonclinical, CMC, commercial, and project teams...RegulatoryWorldwide
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$136.51k - $204.77k
...Title: Associate Director, CMC Lead Introduction to role:... ...ready to lead early-stage CMC strategy that turns precision radioconjugate... .../IMPD Readiness: Lead CMC regulatory strategy; guide and... ...data packages for IND/IMPD submissions. API/Drug Product/Analytical...RegulatoryHourly payTemporary work$237.7k - $356.5k
...DescriptionGeneral Summary:The Senior Director, CMC Product Leader (T1D) will lead the Chemistry, Manufacturing, and... ...and executing integrated CMC strategies across development, scale-up, technology transfer, validation, regulatory submission, and commercialization readiness....RegulatoryFull timeSummer workRemote workFlexible hours2 days per week- ...level Quantitative Scientist for the CMC QS team in Norwood, MA. You will lead a small team delivering advanced... ...and Digital to guide regulatory submissions and data-driven decision making. You will shape scientific strategy, set technical vision, and deploy...Regulatory
$136.51k - $204.77k
...Associate Director leading chemistry, manufacturing, and controls strategy for early-stage alpha-emitting radioconjugate programs. Will develop IND-enabling... ...to drive first-in-human readiness Lead CMC regulatory strategy and author IND/IMPD documentation and data...Regulatory$237k
...Pharmaceuticals seeks a Senior Director to lead Chemistry, Manufacturing, and Controls strategy for Type 1 Diabetes cell therapy... ...The role involves developing integrated CMC plans across development, scale-up, regulatory submission, and commercialization while...Regulatory- ...strategic, tactical and operational regulatory CMC leadership to support... ...and post-approval submissions, along with managing the daily... ...planning regulatory CMC submission strategies, and conducting regulatory CMC... ...CMC will be responsible for leading regulatory CMC activities...Regulatory
$180k - $245k
...and strategic Director of Regulatory Affairs to lead and support global regulatory... ...and executing regulatory strategies that support global product... ...immunology background is preferred. CMC experience is a plus.... ....Lead the preparation, submission, and maintenance of regulatory...Regulatory$202.4k - $265.7k
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$200k - $265k
...believe in our bold ambition to become the leading dermatology company in the world.... ....The OpportunityLeads the global regulatory strategy, submission planning, and health authority engagement... ...clinical, non-clinical, and CMC development documentation as neededQualificationsKnowledge...RegulatoryFull timeTemporary workWork experience placementWork at officeWorldwide$207k - $253k
...Madrigal Pharmaceuticals seeks a Director of Regulatory Affairs CMC to lead chemistry, manufacturing, and controls strategies for clinical and commercial products. The role involves developing regulatory submission strategies, representing the company in health authority...RegulatoryFull time- ...Therapeutics seeks a Director or Senior Director of Regulatory CMC to lead global regulatory strategy for targeted protein degradation programs across development... ...stages. The role encompasses CMC regulatory submissions, health authority interactions, and oversight of manufacturing...Regulatory
$166.4k - $249.6k
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$193.1k - $289.7k
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...Kymera is focused on building an industry-leading pipeline of oral small molecule... ...development and execution of global regulatory CMC strategies for degrader programs across all stages... ...and approve CMC content for regulatory submissions, including INDs/CTAs, briefing...Regulatory
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