Remote Director, CMC Regulatory Strategy
Peptideatlas
- Remote job
Recursion is seeking a Director CMC Regulatory Affairs to lead global regulatory strategy for small molecule drugs in early to late-stage trials. You will influence US, EU, and ROW submissions, coordinate internal/external teams, and ensure marking approvals while aligning with GMP and trial requirements. The role is remote-friendly with some travel to Salt Lake City HQ or other offices as needed. A strong background in CMC, IND/NDAs, and cross-functional collaboration is essential for success #J-18808-Ljbffr Peptideatlas
$177k - $278.08k
...This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and... ...Independently develops the regulatory CMC strategy and leads the execution of... ...following Takeda's Hybrid and Remote Work policy.#LI-Hybrid#LI-AA1...Remote workMinimum wageTemporary workLocal areaWorldwide$148.5k - $257.4k
...provides strategic, tactical and operational regulatory CMC leadership across therapeutic... ...implementation of innovative regulatory strategies and platform approaches based on changes... ...InformationPosition Location: Indianapolis, IN. A remote option may be considered. Relocation...Remote workRelocation packageFlexible hours$246.98k - $299.29k
...com/working-with-us.The GRS-CMC Director is responsible for overseeing... ...direction based on global regulatory guidelines and experience. Seeks... ...effective global regulatory strategies in coordination with... ...capability centers. Employees in remote-by-design or lab-based roles...Remote workHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaFlexible hoursShift work$238k - $374k
...to patients worldwide.As Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination... ...ensure innovative and robust regulatory strategies for medical devices and drug-device... ..." following Takeda's Hybrid and Remote Work policy.#LI-Hybrid#LI-AA1Takeda...Remote workMinimum wageTemporary workWork at officeLocal areaWorldwide$238k - $374k
...knowledge.Job DescriptionExecutive Director, Global Regulatory Affairs CMC Early DevelopmentAre you looking for... ..., compliant global CMC regulatory strategies and submissions for small molecule... ...accordance with Takeda’s Hybrid and Remote Work policyTakeda Compensation and...Remote workMinimum wageTemporary workLocal area- ...purpose. Position Overview - New York, Houston or Remote We are seeking a Director, Regulatory Affairs CMC, to join the Regulatory Affairs CMC team to support... ...Houston to develop, plan, and execute the regulatory strategy to facilitate the achievement of the company’s...Remote workTemporary workShift work
$285k - $320k
...improve clarity, speed, and quality of work. What You'll Do Lead CMC regulatory strategy and execution across development and post‑approval programs... ...and strategies. Where You'll Work This is a U.S.-based remote role that will require quarterly, or as needed visits to...Remote workWork at officeFlexible hours$189k - $246k
...Department: 107000 Regulatory Location: San Diego, USA- Remote Position Summary The Director, Regulatory Affairs Strategy is responsible for developing and executing global regulatory... ...Operations, Medical Affairs, Biostatistics, CMC, Quality, Nonclinical, Commercial, and...Remote workTemporary workLocal areaWeekend work$200k - $250k
...Senior Director, Regulatory Strategy Consulting 4 days ago – Be among the first 25 applicants This range... ...client impact at scale. Work Location: Remote position. Travel may be required to support... ...development, and/or regulatory CMC. Experience across multiple product types...Remote workFull time$207.5k - $255.2k
...Lead development and implementation of CMC regulatory strategy for small molecule investigational... ...and guidance. The Team You’ll Join As Director CMC Regulatory Affairs, you will be an... ...Location & Compensation: This role is remote-friendly, with most work conducted from...Remote workWork at officeLocal areaWork from homeWorldwide$224.9k - $404.6k
Moderna is seeking a regulatory CMC expert to manage a team at their Norwood, MA site. This key leadership role involves overseeing the product strategy for all portfolio products, managing regulatory submissions, and ensuring adherence to quality standards. Ideal candidates...- Marea Therapeutics, based in South San Francisco, seeks a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to lead regulatory strategies and submissions for our US and global programs. The role reports to the Executive Director, Regulatory Affairs...
- Moderna is seeking aRegulatory CMC Senior Leader based in Norwood, MA to manage a team of CMC experts overseeing regulatory correspondence and submissions. You will steer product strategy across portfolio and drive regulatory activities for high-quality CMC sections. You...
- Marea Therapeutics is seeking a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to shape regulatory strategies for manufacturing across the US and global markets. The role reports to the Executive Director of Regulatory Affairs and will own CMC...Work at office2 days per week
- Marea Therapeutics, Inc. is seeking a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to lead regulatory strategies and submissions for US and global manufacturing programs. This role reports to the Executive Director of Regulatory Affairs and requires...Full time
- ...for patients with cancer. Overview The Director, Regulatory CMC, is responsible for leading one or... ...specific emphasis on global regulatory strategy, regulatory submissions, and interaction... ...job operates in a professional or remote office environment and requires operating...Remote workWork at office
$175k - $205k
Sr Manager/Assoc Director, CMC Regulatory Affairs San Diego, CA, South San Francisco, CA or remote Erascais a clinical-stage precision oncology company focused on discovering... ...of appropriate global regulatory filing strategies. Collaborate cross-functionally on the eTMF...Remote workTemporary workCasual workLocal areaWorldwideFlexible hours$199.95k - $242.3k
## Director, Regulatory CMC - Cell TherapyMadison - Giralda - NJ - USFind out how well you match with... ...effective global regulatory strategies in coordination with clinical plans and... ...the capability centers. Employees in remote-by-design or lab-based roles may be eligible...Remote workHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaFlexible hoursShift work$180k - $210.5k
...develops and executes multi-product global regulatory CMC strategies for investigational products and leads the preparation... ...) guidelines Reports to: Executive Director, CMC Regulatory Location: San Carlos, CA / US Remote Work Arrangement: Remote Compensation...Remote work- ...Name Associate Director, Regulatory Affairs – CMC Ref # 15322 Posting Date Tuesday, July 28, 2026 Country... ...8-2026 Work Schedule Full time Remote Work In office Job RI - R&D,... ...for leading the global regulatory CMC strategy for product development and...Remote workPermanent employmentFull timeTemporary workWork at office
- ORIC Pharmaceuticals Inc. in South San Francisco, CA is hiring a Director, CMC Regulatory Affairs to lead regulatory strategies for CMC across oncology programs. You will collaborate with regulatory, quality, clinical, and manufacturing teams to develop regulatory strategies...
- ...will doCurrently seeking a Regulatory Affairs (RA) Manager with strong CMC pre and post approval... ...region functions and Senior Director or Reg CMC Lead, agree on the regulatory strategy for the GRD products life... ...flexible working arrangements, remote work options, and tax...Remote workHourly payWork at officeLocal areaRelocation packageFlexible hours
$190.4k - $285.6k
...DescriptionGeneral Summary:The Director, Chemistry Manufacturing Controls (CMC) leads a Regulatory CMC team responsible for... ...and executing global regulatory strategies across multiple investigational... ...designated as: 1. Hybrid: work remotely up to two days per week; or select...Remote workFull timeSummer workFlexible hours2 days per week$132k - $172k
...patients.Position Summary:The Senior Manager, CMC Regulatory Affairs is responsible for providing... ...and execution of global CMC regulatory strategies to support clinical development,... ...Diego. No role is expected to be 100% remote.Total Rewards Offerings:Travere provides...Remote workFull timeTemporary workWorldwide- ...Associate Director, Regulatory Affairs CMC Founded over a decade ago, CRISPR Therapeutics is a leading... ...and implement innovative Regulatory strategies where little precedent exists. You will... ...a dynamic workplace that balances remote work flexibility with the benefits...Remote workContract work
- Job DescriptionGeneral Summary:The Regulatory Labeling Director will lead the strategic development of... ...(e.g., US, EU, GB, CA).Lead labeling strategy with expert ability to advise stakeholders... ...k) and so much more.Flex Designation:Remote-EligibleFlex Eligibility Status:In...Remote workFull timeSummer workWork at officeLocal areaFlexible hours2 days per week
$116k - $151k
...Position Summary:The Manager, Regulatory Affairs provides regulatory... ...implementation of global regulatory strategies from development through... ...with Clinical, Nonclinical, CMC, Regulatory Operations, Medical... ...role is expected to be 100% remote.Total Rewards Offerings:...Remote workFull timeContract workTemporary work$177k - $278.08k
...changing therapies to patients worldwide.Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the development and... ...the world.This position is currently classified as "remote" in accordance with Takeda's Hybrid and Remote Work policy...Remote workMinimum wageTemporary workLocal areaWorldwide$226.5k - $317.1k
About the RoleThe Senior Director Regulatory Affairs Strategy will play a key role in guiding assigned projects throughout development and lifecycle... ...occasional catered meals. We provide a hybrid work environment; remote work may be considered.We are passionate about our...Remote workWork at officeLocal area- ...A biopharmaceutical company in Redwood City is seeking an Executive Director of Regulatory Affairs CMC to lead the regulatory strategy for drug products. The ideal candidate will have 15 years of regulatory CMC experience and a successful track record in preparing BLAs...
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