Global CMC Manager - Regulatory Submissions & Strategy (Hybrid)
Vertex Pharmaceuticals
Vertex Pharmaceuticals Incorporated seeks a Chemistry Manufacturing Controls Manager to oversee regulatory CMC submissions and strategic interactions with agencies. You will partner with development and manufacturing teams to shape global CMC strategies for investigational and marketed products, while supporting inspections and regulatory readiness. The role requires a strong background in regulatory affairs, cGMP, and experience with Veeva for submissions. Telecommuting is permitted up to 40%. #J-18808-Ljbffr Vertex Pharmaceuticals
- ...Chemistry Manufacturing Controls Manager to lead regulatory CMC activities for both investigational... ...reviewing CMC sections, developing global strategies, and coordinating with cross-... ...teams to ensure compliance and timely submissions. You will act as the primary CMC contact...Suggested
$137k - $215.27k
...role is within the Global Regulatory Affairs (GRA)... ...Manufacturing & Controls (CMC) and Devices... ...or post-approval strategies for assigned... ...robust and accurate submissions.Develops constructive... ..., executes and manages regulatory... ...currently classified as "hybrid" following Takeda...SuggestedMinimum wageTemporary workLocal areaRemote workWorldwide$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... ...factors, risk management, and value messaging... ...currently classified as "hybrid" following Takeda's...SuggestedMinimum 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... ...classified as “hybrid” in accordance with Takeda...SuggestedMinimum wageTemporary workLocal areaRemote work- ...an experienced Associate Director / Director of Regulatory Affairs to lead global regulatory activities and ensure compliance with... ...guidelines. This hands-on role will influence regulatory strategy, prepare and manage submissions, and navigate complex regulatory landscapes....Suggested
- 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...
$211.5k - $258.5k
...Summary The Director, Regulatory Strategy - Global Regulatory Lead is... ...Arrangement & Location Hybrid - This position... ...IND planning, IND/CTA submission strategy, Phase I/II... ...meetings, including management of timelines, briefing... ...with clinical, CMC, and non-clinical development...Local areaFlexible hours2 days per week- Vertex is seeking an Associate Director of CMC to lead global regulatory strategies for biologics, author submissions, and interface with health authorities, leveraging... ...the ability to lead cross-functional teams in a hybrid Boston-area setting. #J-18808-Ljbffr Vertex Pharmaceuticals...
$180k - $245k
...strategic Director of Regulatory Affairs to lead and support global regulatory efforts... ...regulatory strategies that support global... ...background is preferred. CMC experience is a... ...and lifecycle management.Ensure regulatory... ...the preparation, submission, and maintenance of...$200k - $265k
...an unparalleled, direct impact.The OpportunityLeads the global regulatory strategy, submission planning, and health authority engagement for Nemolizumab... ...and documents, including clinical, non-clinical, and CMC development documentation as neededQualificationsKnowledge...Full timeTemporary workWork experience placementWork at officeWorldwide- ...seeking an Associate Director, Regulatory Affairs CMC to lead the development and execution of global regulatory strategies for innovative... ...strong leadership and project management skills, requiring 8-10 years... .... The position allows for hybrid work arrangements, reflective...
$190.4k - $285.6k
...Summary:The Director, Global Submission Management (GSM) is responsible... ...portfolio of global regulatory submissions across... ...with global regulatory strategies and operational... ...Strategy, Regulatory CMC, Labeling, Publishing... ...more.Flex Designation:Hybrid-Eligible Or On-Site...Full timeSummer workRemote workFlexible hours2 days per week- ...join our labeling strategy team. This team is... ...stakeholders. This role is hybrid in either... ...Responsibilities Represent Global Labeling on product-specific Global Regulatory Teams and other... ...Chain to ensure submission-ready labeling... ...to multi-task and manage multiple projects....Local area
$224.9k - $404.6k
Initial Therapeutics, Inc. is seeking a CMC Regulatory Manager based in Norwood, MA. The role involves leading a team of CMC experts to develop and implement regulatory strategies, ensure submission readiness, and manage interactions with health authorities. Ideal candidates...- ...is seeking a Director of Regulatory Affairs - Labeling. This... ...high-visibility role shapes global labeling strategy and partners cross-... ...oversee USPI/CCDS labeling, manage SPL submissions, and drive lifecycle labeling... .... This role supports hybrid in-office engagement amid...Work at officeRelocation
- ...is looking for a Director, Global Regulatory Lead Oncology in Boston, MA.... ...setting the global regulatory strategy and overseeing all... ...to ensure timely and quality submissions to the FDA and other agencies... ...requirements. Opportunities for hybrid work are available. #J-1880...
- ...pharmaceutical company is looking for a Director of Regulatory Affairs to provide strategic and... .... The candidate will prepare regulatory submissions, interact with health authorities like... ...role is vital for supporting ongoing global clinical studies. #J-18808-Ljbffr Noema...
- ...DescriptionGeneral Summary:The CMC Quality Compliance... ..., inspection management, and compliance... ...interpret cGMP regulatory guidelines and... ...level thinking and strategy direction to staff... ...Expert knowledge of global GMP requirements... ...may be required#LI-hybrid #LI-JS1Pay Range:$...Full timeWork experience placementSummer workRemote workFlexible hours2 days per week
$170.9k - $231.3k
...Associate Director, Regulatory Affairs CMC Development is... ...and implementating global CMC regulatory strategies for development-stage... ..., and project management skills. This individual... ....This position is hybrid and primarily... ...Experience with regulatory submissions and health...Full timeTemporary workWork at officeLocal areaFlexible hours- Lilly is seeking an experienced Regulatory CMC leader to develop and implement global CMC strategies for gene therapy programs. You will lead the preparation of CMC sections for IND/CTA, BLA/MAA submissions and serve as the primary liaison with major health authorities...
- ...Pharmaceuticals is seeking an Associate Director, Global Submission Management in Boston to lead a portfolio of global regulatory submissions across development and lifecycle... .... You will partner with Global Regulatory Strategy, CMC, Labeling, Publishing, and Advertising &...
$190.4k - $285.6k
...Manufacturing Controls (CMC) leads a Regulatory CMC team... ...developing and executing global regulatory strategies across multiple... ...preparation, and submission execution.Key Duties... ..., and knowledge management.Ensures programs are... ....Flex Designation:Hybrid-Eligible Or On-...Full timeSummer workRemote workFlexible hours2 days per week- ...Job Description The Senior Manager, Regulatory Affairs US & Canada Strategy Lead is responsible for the... ...Area and supports manager and/or Global Regulatory Lead (GRL) in the development... ...and review of regulatory submissions consistent within US and Canada regulatory...Full timeLocal area
$196.7k - $353.4k
...to lead development and execution of global regulatory strategy for programs in its oncology... ...through commercializationDrive regulatory submissions (INDs, CTAs, BLAs/MAAs) with excellence... ...Demonstrated competence in employee management and development Knowledge of and...Permanent employmentFull timeWork at officeWork from home- ...experienced and visionary Head of Global Regulatory Affairs and Strategy will lead regulatory strategy for... ...Document (eCTD) document management and submission planning. Architect and implement... ...do not hesitate to let us know. Hybrid working It’s hugely important for...Work at office3 days per week
$166.4k - $249.6k
...Manufacturing Controls (CMC) Associate Director leads and executes global regulatory CMC strategies across... ...-quality regulatory submissions, while serving as the... ...review, and lifecycle management of CMC sections of global... ...more.Flex Designation:Hybrid-Eligible Or On-Site...Full timeSummer workRemote workFlexible hours2 days per week$142.5k - $256.5k
...RoleThe Associate Director, Global Regulatory, CMC will be responsible for... ...developing global regulatory CMC strategies and collaborating with key... ...will need to successfully manage multiple projects in a fast... ...strategies for global submissions (e.g. IND/CTA/BLA/MAA) and...Permanent employmentFull timeWork at officeWork from home$182k - $275k
...OverviewRhythm is a global, commercial-stage... ..., and compliant regulatory CMC deliverables for... ...alignment with strategies established by Global... ...the effective management and timely delivery... ...documents and submissions, including core dossiers... ...operates in a hybrid-work model....Work at office$241k - $332k
...Role:As the Head of Regulatory CMC - Biologics &... ...driving the regulatory strategy for biologics and... ...role encompasses global, regional, and... .... You will manage resources, set a... ...continuity.This is a hybrid role to be based... ...approvals.Ensure submission readiness and regulatory...Full timeTemporary workLocal area- ...The Associate Director, CMC Quality Compliance and... ...and Skills:Knowledge of regulatory requirements and... ...limited to: inspection management and risk managementContinuous... ...international travel possible Hybrid-Eligible RolesIn this... ...InformationVertex is a global biotechnology company...Full timeSummer workRemote workFlexible hours2 days per week
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