Hybrid CMC Manager — Regulatory Submissions & Strategy
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Vertex Pharmaceuticals Incorporated is seeking a Chemistry Manufacturing Controls Manager to lead regulatory CMC activities for both investigational and commercial products. The role involves reviewing CMC sections, developing global strategies, and coordinating with cross-functional teams to ensure compliance and timely submissions. You will act as the primary CMC contact, influence regulatory assessments, and support inspections and post-approval changes within the cGMP framework. #J-18808-Ljbffr Socket.dev
$224.9k - $404.6k
Initial Therapeutics, Inc. is seeking a CMC Regulatory Manager based in Norwood, MA. The role involves leading a team of CMC experts to develop and implement regulatory strategies, ensure submission readiness, and manage interactions with health authorities. Ideal candidates...Suggested- ...seeking an Associate Director, Regulatory Affairs CMC to lead the development and... ...of global regulatory strategies for innovative therapeutics... ...strong leadership and project management skills, requiring 8-10... ...leadership. The position allows for hybrid work arrangements,...Suggested
$137k - $215.27k
...within the Global Regulatory Affairs (GRA) Chemistry... ...& Controls (CMC) and Devices organization... .../or post-approval strategies for assigned... ...robust and accurate submissions.Develops... ...plans, executes and manages regulatory submissions... ...currently classified as "hybrid" following Takeda'...SuggestedMinimum wageTemporary workLocal areaRemote workWorldwide- ...Medicines is seeking a Senior Director, Regulatory Affairs CMC - Biologics to lead regulatory... .... You will drive global CMC strategy, author submissions, and coordinate with Process Development... ..., and shape post‑approval change management and lifecycle strategies in a #J-...Suggested
- ...DescriptionGeneral Summary:The CMC Quality Compliance... ...readiness, inspection management, and compliance... ...Monitor and interpret cGMP regulatory guidelines and trends... ...-level thinking and strategy direction to staff and... ...Travel may be required#LI-hybrid #LI-JS1Pay Range:$184,...SuggestedFull timeWork experience placementSummer workRemote workFlexible hours2 days per week
$170.9k - $231.3k
...Associate Director, Regulatory Affairs CMC Development is responsible... ...CMC regulatory strategies for development-... ...collaboration, and project management skills. This... ...landscape.This position is hybrid and primarily... ...Experience with regulatory submissions and health authority...Full timeTemporary workWork at officeLocal areaFlexible hours$238k - $374k
...Executive Director, Global Regulatory Affairs CMC Devices and Drug-... ...robust regulatory strategies for medical devices... ...strategy and major submissions for an assigned portfolio... ...human factors, risk management, and value messaging... ...classified as "hybrid" following Takeda's...Minimum wageTemporary workWork at officeLocal areaRemote workWorldwide$238k - $374k
...DescriptionExecutive Director, Global Regulatory Affairs CMC Early DevelopmentAre you... ...global CMC regulatory strategies and submissions for small molecule and... ..., data and knowledge management, and digital CMC dossiers... ...currently classified as “hybrid” in accordance with...Minimum wageTemporary workLocal areaRemote work$190.4k - $285.6k
...Manufacturing Controls (CMC) leads a Regulatory CMC team responsible... ...global regulatory strategies across multiple... ...document preparation, and submission execution.Key Duties... ..., and knowledge management.Ensures programs are... ...more.Flex Designation:Hybrid-Eligible Or On-Site...Full timeSummer workRemote workFlexible hours2 days per week- ...Instagram, X and YouTube. Job Description The Senior Manager, Regulatory Affairs US & Canada Strategy Lead - Therapeutic Neurotoxins is responsible for... ...responsible for the preparation and review of regulatory submissions consistent within US and Canada regulatory...Local area
$166.4k - $249.6k
...Manufacturing Controls (CMC) Associate Director... ...and executes global regulatory CMC strategies across investigational... ...-quality regulatory submissions, while serving as the... ...review, and lifecycle management of CMC sections of... ...more.Flex Designation:Hybrid-Eligible Or On-Site EligibleFlex...Full timeSummer workRemote workFlexible hours2 days per week$182k - $275k
...based, and compliant regulatory CMC deliverables for assigned... ...), in alignment with strategies established by Global... ...for the effective management and timely delivery... ...regulatory documents and submissions, including core... ...Rhythm operates in a hybrid-work model. Candidates...Work at office$241k - $332k
...This Role:As the Head of Regulatory CMC - Biologics & Advanced... ...the regulatory strategy for biologics and ATMPs... ...modalities. You will manage resources, set a vision... ...continuity.This is a hybrid role to be based at our... ...product approvals.Ensure submission readiness and regulatory...Full timeTemporary workLocal area- ...monitoring, population health management tools, and a CDC-... ..., Revenue Cycle Strategy, Partnerships & Operations... ..., coding, claims submission, denial management, payment... ...; operationalize regulatory updates quickly and effectively... ...the office. This is a hybrid role, onsite in the...Full timeTemporary workPart timeWork at officeRemote workRelocationFlexible hours
$204k - $245k
...Director, Regulatory CMC Somerville, MA At Genetix... ...global CMC regulatory strategies for approved and late... ...primary focus on lifecycle management, change management,... ...post-approval submissions, inspection readiness... ...This is a full-time hybrid position (3 days a week...Full timeWork at officeFlexible hours3 days per week- ...Summary:The Associate Director, CMC Quality Compliance and... ...forumsKnowledge and Skills:Knowledge of regulatory requirements and inspection... ...not limited to: inspection management and risk managementContinuous... ...travel possible Hybrid-Eligible RolesIn this Hybrid-...Full timeSummer workRemote workFlexible hours2 days per week
- Relay Therapeutics in Cambridge, MA is seeking a motivated regulatory professional to join their dynamic team. You will support innovative regulatory strategies and manage global submissions including IND, CTA, NDA, and MAA. The ideal candidate has a B.S./M.S. with 2+ years...
- 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...
$150k - $195k
...life fully. Job Summary: The Senior Manager, Regulatory Strategy supports the development and execution... ...activities and involvement in ex‑US submissions including EMA filings. Working cross‑... ...environment. Work Arrangement & Location: Hybrid - This position follows a hybrid work...Local areaFlexible hours2 days per week- ...seeking an experienced Associate Director / Director of Regulatory Affairs to lead global regulatory activities and... ...guidelines. This hands-on role will influence regulatory strategy, prepare and manage submissions, and navigate complex regulatory landscapes. Ideal candidates...
$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...$168k - $252k
...DescriptionGeneral Summary:The Regulatory Strategy Associate Director will be... ...process for preparation, submission, and approval of regulatory... ...teams and senior management on regulatory risks, considerations... ...much more.Flex Designation:Hybrid-Eligible Or On-Site EligibleFlex...Full timeSummer workRemote workFlexible hours2 days per week$211.5k - $258.5k
...Summary The Director, Regulatory Strategy - Global Regulatory... ...Arrangement & Location Hybrid - This position... ...IND planning, IND/CTA submission strategy, Phase I/II/... ...meetings, including management of timelines, briefing... ...alignment with clinical, CMC, and non-clinical development...Local areaFlexible hours2 days per week$193.5k - $354.75k
...defining the future direction of CMC regulatory submissions and ensuring alignment between regulatory strategy, development data strategies,... ...is for the role to be hybrid, being on-site at one of the... ...Exceptional communication, stakeholder management, and collaboration skills....Full timeLocal area2 days per week$242k - $313.5k
Senior Director, Regulatory Affairs CMC - Biologics About Beeline... ...CMC regulatory strategies from early clinical... ...‑approval lifecycle management, serving as the company... ...Arrangement & Location: Hybrid - This position... ...of global regulatory submissions in ICH CTD format, including...Local area2 days per week$268.2k - $402.2k
...Summary:The Executive Director, Regulatory Strategy will serve as a seasoned... ...portfolio. This position will manage a group of global/regional... ...authorship and quality of regulatory submission documents and Health... ...much more.Flex Designation:Hybrid-Eligible Or On-Site EligibleFlex...Full timeSummer workLocal areaRemote workFlexible hours2 days per week$174.5k - $274.23k
...worldwide. The Director Regulatory Site CMC ensures efficient and compliant management of regulatory change... ...communicate regulatory strategy to drug development,... ...evaluations and regulatory submissions (considering possible... ...classified as “hybrid” following Takeda’s Hybrid...Minimum wageTemporary workLocal areaRemote workWorldwide- ...Biotherapeutics in Somerville is seeking an Associate Director of Quality Compliance to oversee regulatory submissions and lifecycle management of GTX products. This full-time hybrid role demands strong expertise in quality assurance, with responsibilities including...Full time
$180k - $245k
...strategic Director of Regulatory Affairs to lead and support... ...executing regulatory strategies that support global... ...is preferred. CMC experience is a plus.ResponsibilitiesDevelop... ...and lifecycle management.Ensure regulatory... ...Lead the preparation, submission, and maintenance of...$232k - $348k
Job DescriptionThe Regulatory Strategy Senior Director is a regulatory leader... ...and strategy.This is a hybrid position requiring 3 days/week... ...including for regulatory submission documents and Health Authority... ...and advises senior management on status of global Regulatory...Full timeSummer workWork at officeLocal areaRemote workFlexible hours2 days per week3 days per week
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