Senior Director, Global CMC Regulatory Strategy
Kardigan, Inc.
Kardigan is seeking a Senior Director, CMC Regulatory to lead CMC regulatory strategies and drive global submissions for late-stage assets. The role reports to Head of CMC Regulatory and collaborates with cross-functional teams across development and manufacturing in Princeton, NJ (onsite four days per week).
The successful candidate will manage health authority interactions, ensure compliance with FDA, EMA and ICH guidelines, and shape regulatory strategies to support marketing approval while
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$229.38k - $277.96k
...Bristol Myers Squibb seeks a Senior Director to lead global medical strategy for its Mood Disorders portfolio across development and commercialization.... ...Serve as senior medical partner across commercial, regulatory, and R&D teams on strategic decisions Partner with...SeniorRegulatory$229.38k - $277.96k
...Senior Director position leading global medical strategy for Bristol Myers Squibb's neurology portfolio, focusing on Neuroimmune, Neuromuscular, and Motor neuron... ...integrator across Medical, Brand, Commercial, Regulatory, and other cross-functional teams Oversee medical...SeniorRegulatory- ...Senior Director, Global Regulatory Strategy, NeuroscienceWill be a key member of the GRSP Extended Leadership Team to ensure the development, implementation... ...expert in one or more key areas – Drug Development/CMC/Pharmtox/ Biopharmaceutics/Clinical/Promotional.Inter-dependent...SeniorRegulatory
$175k - $192.5k
Kyowa Kirin is a global specialty pharmaceutical company backed... ...more at .Summary:The Associate Director, Global Project Management... ...project integrator to align strategy, execution, and decision-... ...including clinical, nonclinical, CMC, regulatory, and commercialization...RegulatoryContract workSummer workWork at officeLocal areaWorldwide- ...Bristol Myers Squibb seeks a GRS-CMC Director to oversee multiple development and lifecycle management projects, guiding regulatory strategy in CMC to support global filings. You will lead cross-functional teams, mentor staff, and represent BMS in Health Authority meetings...Regulatory
$196.7k - $353.4k
The Role:Moderna Therapeutics is seeking a Sr. Director of Regulatory Strategy to support oncology programs to be based in its Cambridge headquarters... ..., will be relied on to articulate clear and compelling global regulatory strategies, highlighting risks and...SeniorRegulatoryPermanent employmentFull timeWork at officeWork from home- ...Position Summary The Senior Director, PDS Learning is accountable... ...for the enterprise learning strategy, operating model, governance... ...efficiently. This leader sets the global direction for GxP and... ...translates PDS priorities and regulatory expectations into scalable learning...SeniorRegulatoryLocal areaShift work
$194.72k - $292.08k
...champion and maintain a global workplace where... ...OpportunityGenmab is creating the Director, Global... ...alignment with evolving regulatory expectations.Develop and... ...enterprise-wide AI and data strategy discussions, ensuring... ...to earn trust among senior analytics professionals...RegulatoryFull timeTemporary workFixed term contractWork at office$243k - $297k
...alert: Create Alert Title: Senior Director, Medical Affairs,... ...patients, Sun Pharma is a leading global pharmaceutical company, providing... ...and executing medical strategy, while also leading, coaching... ...Relations, Market Access, and Regulatory teams to shape product strategy...SeniorRegulatoryWork at officeLocal areaFlexible hours$260.77k - $315.99k
...company’s performance. The Senior Director role requires a proactive... ...managing, and executing the global investor relations program.... ...Accountabilities Leadership & Strategy Assist in developing... ...manner & in line with Company & regulatory agency policies. Ensure...SeniorRegulatoryFull timeSummer workLive inRemote workFlexible hours$166.35k - $201.57k
...Responsibilities Reporting to the Director, Professional... ...with BMS oncology strategy.Managing Oncology & Hematology... ...relationships with senior leaders within key... ...required.Partners with the Global Medical Oncology... ...company policy, legal and regulatory requirements....RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeRemote workFlexible hoursShift work$220k - $240k
...Pharma is a dynamic, fast-growing global biopharmaceutical company... ...an experienced and strategic regulatory affairs leader looking for an... ...to shape global labeling strategy and optimize operational execution... ...strategy. The role As Director, Head of Global Labeling, you...RegulatoryTemporary workWork at officeLocal areaWorldwideFlexible hours- ...Freyr Inc. is a leading global Regulatory Solutions and Services company... .... Job Title: Associate Director, Global RA Labeling Lead... ...position will lead labeling strategy across development and marketed... .... Ability to influence senior stakeholders without direct...RegulatoryPermanent employmentRemote work
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$239.08k - $289.71k
## Executive Director, Neuroscience Global Commercial StrategyPrinceton - NJ - USFind out how... ...Neuroscience Global Commercial Strategy will serve as a senior commercial leader accountable for... ...partnering with Development, Medical, Regulatory, CMC, Commercial, and Strategy &...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workWorldwideFlexible hoursShift work- ...Scorpion Therapeutics seeks a Senior Director, Global Medical Neuroscience – MPL for Specialty Neurology to steer worldwide medical strategy for Neuroimmune, Neuromuscular, and Motor neuron... ...-functional teams across Clinical, Regulatory and Commercial functions and build a...SeniorRegulatoryWorldwideFlexible hours
$186.49k - $278.88k
## Associate Director, Global Medical ReviewApplylocations: Princeton, NJtime type: Full timeposted... ...Product Leaders, PV Operations, Regulatory Affairs, Clinical Development, Quality... ...implementation of the Medical Review strategy and objectives, ensuring alignment with...RegulatoryTemporary workLocal areaFlexible hours- ...in Princeton, NJ seeks a Sr. Director & Associate General Counsel to... ...litigation and provide senior legal counsel to business leaders... ...role, you will collaborate with global teams, manage internal... ...risk management while ensuring regulatory compliance and strong corporate...SeniorRegulatory
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$162.64k - $243.96k
...create, champion and maintain a global workplace where individuals’... ...in Princeton.As an Associate Director of Drug Safety and... ...with stakeholders ranging from regulatory authorities and colleagues from... ...to the development of safety strategy and safety deliverables for assigned...RegulatoryFull timeFixed term contractWork at officeRemote work- ...Novo Nordisk is seeking an Associate Director for the NovoCare Mobile Platform to shape... ...relationships. You will translate marketing strategy into engaging, compliant mobile... ...collaborating with brand teams, medical, legal, regulatory and analytics partners in a regulated...SeniorRegulatory
$155.54k - $188.48k
...Position SummaryThe Associate Director, Global Medical Neuroscience Medical... ...of medical communications strategies across the BMS Neuroscience... ...role partners closely with the Senior Director, Global Medical... ...Medical Strategy, Commercial, Regulatory, Safety, and HEOR — providing...RegulatoryHourly payFull timeContract workTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work- ...Ascendis Pharma is seeking a strategic Director, Head of Global Labeling to lead the worldwide... ...governance bodies, shape development labeling strategies, and collaborate across Legal,... ...Affairs, and Market Access to drive regulatory excellence. The role requires deep...RegulatoryWorldwide
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$196.7k - $353.4k
...Moderna, Inc. is seeking a Sr. Director of Regulatory Strategy to lead Regulatory Strategy... ...new drug modality globally. The Sr. Director will be a... ...data in partnership with RA CMC and verifies accuracy of clinical... ...the Project Team and senior management, as relevant.May...SeniorRegulatoryPermanent employmentFull timeWork at officeWork from home$215.5k - $239.5k
Senior Director, Quantitative PharmacologySun Pharma is the world’s fourth largest specialty generics... ...and teamwork. As part of the global team, you will collaborate with talented... ...clinical operations, drug metabolism, regulatory affairs, and late-stage clinical researchMentoring...SeniorRegulatoryWorldwideFlexible hours$236k - $314k
...benefits.Position SummaryThe Senior Director, Health Economics and... ...generation and will oversee global pharmacoeconomic models, evidence... ...be responsible for pricing strategies and access architecture to optimize... ...reimbursement dynamics and regulatory environments.Experience with...SeniorRegulatoryFull timeTemporary workLocal areaShift work$105.4k - $207.8k
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