Senior Director, CMC Regulatory Strategy
RXinsider LTD.
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 will lead interactions with health authorities, develop regulatory processes, and ensure submissions meet guidelines. Strong leadership, communication, and extensive CMC experience are essential. #J-18808-Ljbffr RXinsider LTD.
$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...Suggested$218.06k - $327.09k
Job Title: Senior Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg, MDBoston, MASouth San Francisco, CASanta Monica,... ...presentations and aligning regulatory objectives with clinical, CMC, safety and commercial strategies.Evidence and Decision...SeniorHourly payFull timeTemporary workStart working todayWork at officeFlexible hours3 days per week$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$137k - $215.27k
...patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute... ...investigational, registration and/or post-approval strategies for assigned products.RA CMC member on the...SeniorMinimum wageTemporary workLocal areaRemote workWorldwide$212k - $333.19k
...life‑changing therapies to patients worldwide. As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug‑Device Combinations Human Factors,... ...innovative pure device and combination product regulatory strategies particularly pertaining to the development,...SeniorMinimum wageFull timeTemporary workLocal areaWorldwideNight shift$163.5k - $281.6k
...invite you to join us. Eli Lilly and Company is seeking a highly experienced and strategic Director/Senior Director, Regulatory CMC to lead and execute regulatory CMC strategies for our cutting-edge gene therapy portfolio. This role will be critical in shaping the regulatory...SeniorFor contractorsWork at officeFlexible hours$232k - $348k
Job DescriptionThe Regulatory Strategy Senior Director is a regulatory leader with expert technical and tactical experience in regulatory strategy for the assigned global or regional position and will be responsible for overseeing the development and implementation of advanced...SeniorFull timeSummer workWork at officeLocal areaRemote workFlexible hours2 days per week3 days per week$240k - $320k
...unparalleled, direct impact.The OpportunityThis role leads US regulatory policy and advocacy efforts to support the advancement and lifecycle... ...and US-based teams, this role develops science-driven policy strategies, engages with regulatory agencies and external stakeholders,...SeniorFull timeTemporary workWork experience placementWork at officeWorldwide$224.9k - $404.6k
...and will be responsible for managing a team of CMC experts that prepare and oversee CMC and Quality related agency correspondence and regulatory applications. This position will be required to oversee the product strategy for all the products in their portfolio and lead...Permanent employmentFull timeWork at officeWork from home$142.5k - $256.5k
The Role:The Associate Director, Global Regulatory-CMC will be responsible for coordinating regulatory CMC activities for one or more products,... ...will be responsible for developing global regulatory CMC strategies and collaborating with key stakeholders to execute the strategies...Permanent employmentFull timeWork at officeWork from home$275k - $315k
...Therapeutics is seeking a strategic and experienced Senior Director of Regulatory Affairs to lead and execute US regulatory strategy for our biologics pipeline. Reporting to the... ...-functional teams (Clinical, Nonclinical, CMC, Biostatistics, Clinical Operations, Medical Affairs...SeniorFull timeTemporary workWork at officeLocal area3 days per week- ...stability studies, interpret data, and support shelf-life and regulatory submissions for development, clinical, or commercial programs.... ...and other stake- holders to ensure compliant product control strategies and uninterrupted supply. #J-18808-Ljbffr Initial Therapeutics...Senior
$200k - $220k
...Director/ Senior Director, Regulatory CMC Join Us in Tackling Autoimmune Disease at Its Root At Vor, we believe science can do more than manage symptoms... ...career in science, clinical development, commercial strategy, and beyond. Innovation: Work on a platform with potential...SeniorContract workWorldwideFlexible 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... ...functional stakeholders.Serves as senior Regulatory CMC representative...Full timeSummer workRemote workFlexible hours2 days per week$180k - $245k
...seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory... ...developing and executing regulatory strategies that support global product... ...and immunology background is preferred. CMC experience is a plus.ResponsibilitiesDevelop...$182k - $275k
...Opportunity OverviewThis role is responsible for executing high-quality, science-based, and compliant regulatory CMC deliverables for assigned program(s), in alignment with strategies established by Global Regulatory Affairs and Technical Operations.This individual contributor...Work at office$189k - $246k
...Department: 107000 Regulatory Location: San Diego, USA- Remote Be a part of... .... Position Summary: The Director, Regulatory Affairs Strategy is responsible for developing and executing... ..., Medical Affairs, Biostatistics, CMC, Quality, Nonclinical, Commercial,...Temporary workLocal areaRemote workWeekend work$142.5k - $256.5k
Role Overview The Associate Director, Global Regulatory-CMC will coordinate regulatory CMC activities for one or more products throughout their lifecycle, develop global regulatory CMC strategies, collaborate with stakeholders, and manage multiple projects to support the...$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... ...Global Regulatory Affairs in senior-level governance and in interactions...Minimum wageTemporary workWork at officeLocal areaRemote workWorldwide$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... ...Represents Global Regulatory Affairs CMC in senior-level governance and in...Minimum wageTemporary workLocal areaRemote work$190k - $215k
...required Monday-Wednesday Your Impact: As Associate Director, Regulatory Strategy, you'll help define the regulatory path for our small-... ...advise to cross-functional team members including clinical, CMC, clinical pharmacology, and nonclinical Accountable for...Full timeWork at officeLocal areaImmediate start$235k - $335k
...and heard.How you’ll make an impact:Kymera is seeking a Senior/Executive Director, AI Strategy & Applications to serve as the company's first... ...platforms, and partner across Research, Clinical Development, Regulatory/CMC, and G&A to turn scientific and business challenges...Senior$166.4k - $249.6k
Job DescriptionGeneral Summary:The Chemistry Manufacturing Controls (CMC) Associate Director leads and executes global regulatory CMC strategies across investigational and commercial products focusing on biologics. This role is accountable for authoring, reviewing, and...Full timeSummer workRemote workFlexible hours2 days per week- Moderna Therapeutics is seeking a Senior Data Product Manager who will own prioritization, definition... ...products and AI use cases across Moderna's CMC organization. This role sits at the intersection of business process, data strategy, and applied AI, translating operational...Senior
- MWRA in Chelsea, MA seeks a Director of Procurement to lead all procurement strategy, compliance and training. You will oversee policies, competitive procurement, and contract documentation while guiding staff on state law adherence. The role requires a strong background...SeniorContract work
- Job DescriptionGeneral Summary:The Regulatory Labeling Director will lead the strategic development of... ...specific global regulatory teams and senior labeling governance meetings: Label Review... ...(e.g., US, EU, GB, CA).Lead labeling strategy with expert ability to advise...Full timeSummer workWork at officeLocal areaRemote workFlexible hours2 days per week
$276k - $414k
Job Title: Executive Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg, MDBoston, MASouth San Francisco, CASanta... ...submissions across multiple indications and modalities. As a senior leader, you will build capability, coach regulatory...Hourly payFull timeTemporary workWork at officeWorldwideFlexible hours3 days per week$268.2k - $402.2k
Job DescriptionGeneral Summary:The Executive Director, Regulatory Strategy will serve as a seasoned regulatory leader with expert technical and tactical... ...within the T1D portfolio, representing regulatory on the senior cross-functional teams providing strategic input and...Full timeSummer workLocal areaRemote workFlexible hours2 days per week$212k - $333.19k
...a lasting impact on patients worldwide.Join Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you will be part of the global regulatory... ...complex challenges and ideas into actionable strategies. You will set global regulatory direction, provide expert...SeniorMinimum wageTemporary workLocal areaRemote workWorldwide$121.6k - $194.5k
The RoleThe Senior Data Product Manager will own the prioritization... ...use cases across Moderna's CMC organization. This role operates... ...process knowledge, data strategy, and applied AI, translating... ...to the nature of the work and regulatory requirements, only individuals...SeniorPermanent employmentFull timeWork at officeWork from home
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