Associate Director, Regulatory Systems & Capabilities
Takeda Pharmaceutical Company Ltd
Takeda Pharmaceutical Co. is seeking an Associate Director to drive regulatory business systems and capability strategy from Boston, MA. You will translate regulatory needs into scalable system capabilities, align stakeholders, and enable structured requirements for efficient, compliant delivery.
Your background in Regulatory Affairs and experience with regulatory systems will help shape roadmaps, manage demand, and foster process improvements across global teams.
#J-18808-Ljbffr$154.4k - $242.55k
Job Description Objective / Purpose The Associate Director, Regulatory Business Systems & Capability Strategy supports the definition and execution of regulatory capability strategy within GRIDS. This role partners with Business System Owners and Business Process Owners...SuggestedMinimum wageFull timeLocal areaWorldwide$170.9k - $231.3k
OverviewThe Associate Director, Regulatory Affairs CMC Development is responsible for developing and implementing... ..., and next-generation delivery systems. This role serves as a key bridge... ..., processes, and organizational capability.QualificationsAdvanced degree in chemistry...SuggestedFull timeTemporary workWork at officeLocal areaFlexible hours$148.5k - $214.5k
Job title: Associate Director - QSP Quantitative Systems PharmacologyLocation: Morristown, NJAbout the JobAt Sanofi... ..., disease modeling, and regulatory expectations for model-informed drug... ...mentor others to develop similar capabilities.About You Ph.D. in Biomedical Engineering...SuggestedFull time$143k - $233k
Associate Director/Director, CMC Regulatory Cambridge, MA As part of the Pharmaceutical Development team, this position... ...pressure. Strategic thinking capabilities with forward looking perspective... ...(s) and/or other supports Nervous system condition, for example, migraine headaches...SuggestedContract workFor contractorsFor subcontractorWork at office- ...Associate Director, Global Regulatory Project Management And Strategic Planning - Oncology TauAt Takeda, we are... ...regulatory information management systems, preparing, checking and tracking regulatory... ...and with attention to detail; capable of managing multiple projects within...SuggestedRemote workWorldwide
$177k - $278.08k
...Description Objective / Purpose The Director, Innovation leads the GRIDS... ...initiatives across Global Regulatory Affairs. This role ensures... ...innovation is managed as a disciplined capability, enabling both rapid improvements and strategic system advancements aligned with GRA...Minimum wageFull timeInterim roleLocal areaWorldwide$162.8k - $244.2k
## Associate Director, Heme Global Business SystemsApplylocations: Boston, MAtime type: Full timeposted... ...Associate Director, Heme CGT Business Systems**to lead global system strategy for... ..., and prioritization for commercial capabilities supporting the Heme Franchise* Partner...Work experience placementSummer workRemote workWorldwideFlexible hours2 days per week- ...modellers, where one will use Quantitative Systems Pharmacology, mathematical modelling,... ..., analysis plans, study reports and regulatory submissions as appropriate. Work in close... ...in demonstrating your strengths and capabilities contact us on ****@*****.***...Local area
- ...physical lab space, R&D capabilities, AI/ML tools, and decades... .... Job Summary The Senior Director will lead the regulatory and medical writing function... ..., vendor management, systems management, systems implementation... ...ExploR&D portfolio and associated asset development, as it...Full timeRemote workRelocationFlexible hours
$162.8k - $244.2k
...Job Description General Summary The Associate Director, Health System Engagement & Congress Lead is responsible for developing the strategy and... ...curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation,...Contract workWork experience placementSummer workRemote workFlexible hours2 days per week$166.4k - $249.6k
...Summary:The Chemistry Manufacturing Controls (CMC) Associate Director leads and executes global regulatory CMC strategies across investigational and... ...and data traceability approachesSupports AI/digital capability developmentContributes to process improvements and...Full timeSummer workRemote workFlexible hours2 days per week$162.8k - $244.2k
Job DescriptionGeneral Summary:The Health Systems / HCP Marketing Associate Director is responsible for the development and execution of key personal... ...curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation,...Full timeSummer workRemote workFlexible hours2 days per week$177k - $278.08k
...About the Role The Director, Regulatory Capability Development and Knowledge Management will lead the strategy, design,... ...skills gaps and prioritize development needs associated with new and existing processes, systems, and organizational changes. Identify critical...Minimum wageFull timeLocal areaWorldwide- ...locations. Role overview: This is a hands-on strategic regulatory intelligence delivery and execution role. You will scope,... ...professionals sit at the intersection of our sales, analyst and AI capabilities. Their work spans the full end-to-end process Scope...Remote work
$167.65k - $207.1k
...and business needs. Job Summary The Associate Director, Regulatory Operations is a hands-on leader who... ...over the processes, standards, and systems that enable Regulatory Affairs to operate... ...direction, plan and build capabilities, and deliver timely, high-quality submissions...Work at officeRelocationFlexible hours$142.5k - $256.5k
...changing the biotech industry.Reporting to the Director, Regulatory Information Management (RIM), the Associate Director, Regulatory Data Management & Intelligence... ...ecosystem. This role serves as the Business Capability Owner for assigned Veeva Vault RIM Data capabilities...Permanent employmentFull timeFor contractorsWork at officeWork from home$170.9k - $231.3k
OverviewThe Associate Director of Regulatory Affairs Strategy will work on assigned programs with the respective Global Regulatory Portfolio Lead,... ...levels and with CROs and external consultants.Technical system skills (e.g. word processing, spreadsheets, databases, online...Full timeTemporary workLocal areaWorldwideFlexible hours2 days per week$150k - $214k
The Opportunity Reporting to the Executive Director, Head of Regulatory Project Management, you will support the planning, coordination, and execution... ...priorities. Proficiency with project management tools and systems used to support regulatory planning and execution e.g....Work at office$160.8k - $201k
...robust portfolio of programs across muscle, central nervous system, and cardiac diseases. In 2023, we launched our fourth... ...benefits, see our website: The Importance of the Role The Associate Director, Regulatory Labeling and Disclosures, will be responsible for leading...Work at officeLocal areaImmediate startWorldwide$153.6k - $241.34k
Associate Director, Access Marketing Capabilities and Development Join to apply for the Associate Director, Access Marketing Capabilities and Development role... ...community. You will define the capabilities, systems and strategic partnerships that equip our organization...Minimum wageFull timeTemporary workLocal areaNight shiftWeekend work$161.5k - $242.3k
...DescriptionGeneral SummaryThe Associate Director, GxP Operations Support Manufacturing Systems will provide strategic leadership... ...agile digital manufacturing capabilities.The Associate Director will... ...remain compliant with applicable regulatory requirements including GMP,...Full timeSummer workFlexible hours$153.54k - $230.31k
...Sr. Manager/Associate Director, G&A Business Systems Analyst, ITAt Agios, we are fueled by connections to transform rare diseases. We foster an inclusive... ...the UAT process, ensuring stakeholders understand capabilities, test complete solution and supporting data for user experience...Temporary workWork experience placementRemote workWork from homeFlexible hours3 days per week$175.8k - $237.8k
OverviewThe Associate Director, Quantitative Systems Pharmacology (QSP) will support a rapidly expanding clinical portfolio of promising RNAi therapeutics... ...experience in pharmaceutical industry, consulting, or regulatory agency.Track record of application of QSP modeling to...Full timeTemporary workLocal areaFlexible hours$154.4k - $242.55k
...resource demand forecasting, availability and capacity planning capability delivered through CAPTIVATE, Takeda R&D's Planisware platform.... ...and thought partner for R&D, ensuring common process, consistent system utilization, accurate data aggregation and decision-ready...Minimum wageFull timeLocal areaWorldwide$190k - $210k
...Associate Director, Global Regulatory Affairs ComplianceOlema Oncology is a clinical-stage biopharmaceutical company committed to transforming the... ...on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for...Work at officeFlexible hours2 days per week- ...cancer. What you'll be doing As a key member of the Nuvation Regulatory Affairs team, you will collaborate with a cross-functional team... ...product regulatory requirements Familiar with eCTD, e-publishing systems, and direct experience in preparing regulatory submissions is...Full timeFor contractorsLocal area
$175k - $220k
...The Opportunity Precede Biosciences is seeking a hands-on Associate Director of Regulatory Affairs to lead regulatory strategy and execution for our... .... Embed regulatory requirements in the quality system. Contribute to design and development controls, risk management...- ...Job Description Reporting the Head of Europe, Regulatory Policy & Intelligence. Position Overview: The Associate Director, Europe Regulatory Policy & Intelligence (RPI... ...impact, in the external environment is a key capability for this role. Policy experience in life...Local area
$175k - $225k
...ScholarRock on X and on LinkedIn. Summary of Position: The Associate Director, Regulatory Strategy, is responsible for the development and... ...written, verbal communication skills, and interpersonal skills Capable of managing shifting priorities in a rapidly changing and...Shift work- ...Harvard University is seeking an Associate Director of Student Funding within the Office for Graduate Education (OGE) to provide strategic... ...shape policies, implement new funding workflows, and modernize systems in partnership with University Information Systems and...Work at office
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