Global Regulatory Platform Lead, Human Factors & Devices
Takeda Pharmaceuticals
Takeda is looking for a Senior Director and Regulatory Platform Lead in Boston, MA, to lead the development of innovative regulatory strategies for device and drug-device combinations. This position requires over 10 years of experience in the pharmaceutical industry, with a strong emphasis on Human Factors, regulatory submissions, and cross-functional collaboration. The successful candidate will be responsible for guiding regulatory strategies, interfacing with global health authorities, and ensuring high-quality regulatory filings. This role also involves leadership and mentorship within the regulatory team. #J-18808-Ljbffr Takeda
$212k - $333.19k
...patients worldwide. As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug‑Device Combinations Human Factors, you will provide leadership for the development... ...prospective and proactive implementation. Globally influence and serve as a key opinion leader...PlatformRegulatoryMinimum wageFull timeTemporary workLocal areaWorldwideNight shift- Job title: Global Submission Lead Location: Morristown, NJ / Cambridge, MA. About the job As Global... ..., coordination, and tracking of regulatory Priority portfolio and Integration submission... ...cutting-edge AI, data, and digital platforms to push the boundaries of science....PlatformRegulatoryWorldwideFlexible hours
- ...Katalyst CRO in Boston is seeking a Regulatory Affairs professional to lead CMC strategies for investigational products. The candidate will interact with Health Authorities and manage regulatory submissions to ensure compliance and success. With a foundation in regulatory...Regulatory
$151.75k - $227.63k
...Reporting to VP Global Head Patient Experience, this position is... ...team and is responsible for leading the Global patient advocacy strategy... ...and caregivers within those platforms ~ Promote patient-... ...of current compliance, legal, regulatory and other issues that impact...PlatformRegulatoryTemporary workWork at officeLocal areaFlexible hours3 days per week$238k - $374k
...As Executive Director, Global Regulatory Affairs CMC Early... ...substance/drug product, device/combination where applicable... ...You Will Contribute Leads and develops a team of... ...fit‑for‑phase and platform approaches in early development... ...is an important factor as you consider the...PlatformRegulatoryFull timeTemporary workLocal areaWorldwide- ...for each vendor and software platforms. This includes main campus and... ..., radiologists, CT Division lead radiologists to ensure exam protocols... .... Assist in oversight of regulatory requirements pertaining to CT... ...(34-66%) 35lbs+ (w/assisted device) Carrying Frequently (34-66%)...PlatformRegulatoryWork at office
- ...day. We are seeking a Global Trade Compliance Director... ...that supports regulatory compliance, enterprise... ...regulatory engagements. Lead global customs, import... ...compliance technology platforms, including SAP GTS, automation... ...industry, such as medical device, pharmaceutical,...PlatformRegulatoryWork at officeLocal areaRelocationRelocation package3 days per week
$196k - $269.5k
## Director, Global Indication Lead, RheumatologyApplylocations: Boston, MA, USAtime type: Full timeposted... ...* Deep understanding of the legal, regulatory and commercial environment across... ...posted range when justified by these factors. Because market conditions evolve, pay...RegulatoryTemporary work$47 - $67.74 per hour
...vendor and software platforms. This includes... ...radiologists, CT Division lead radiologists to... ...in oversite of regulatory requirements pertaining... ...5lbs+ (w/assisted device) ~... ...and other essential factors. The base pay information... ...may contact Human Resources at (857)...PlatformRegulatoryHourly payWork at officeRemote workShift work$154.4k - $242.55k
...Job Description The Global Brand Lead, ITP (Associate Director) is responsible for driving global... ...closely with Medical, Legal, and Regulatory teams to ensure materials are compliant... ...understand compensation is an important factor as you consider the next step in your career...RegulatoryMinimum wageFull timeTemporary workLocal area$238k - $374k
...worldwide. As Executive Director, Global Regulatory Affairs CMC Devices and Drug‑Device Combination Product... ...China). How you will contribute: Leads and develops a team of regulatory leaders... ...evidence generation, usability/human factors, risk management, and value...RegulatoryMinimum wageFull timeTemporary workWork at officeLocal areaRemote workWorldwide$170k - $282.5k
...management and subsidiary governance to lead our Global Legal Entity Governance team. The... ...creation, maintenance, dissolution and regulatory compliance activities of various types... ...Diligent Entities legal entity management platform and similar tools.Salary Range:$170,000...PlatformRegulatoryTemporary workWork at officeFlexible hours- ...Scholar Rock is a late-stage global biopharmaceutical... ...application of a proprietary platform, which has developed... ...protein growth factors with extraordinary selectivity... ...of quality systems and regulatory compliance across... ...the organization grows. Lead validation of GxP computerized...PlatformRegulatory
$73.35k - $122.25k
The Global Compliance Testing Team is seeking... ...the company GRC platform (e.g., Archer or similar... ..., and applicable regulatory requirements... ...Corporation is a leading international financial... ...to employment. A Human Resources... ...relevant job‑related factors such as knowledge,...PlatformRegulatoryTemporary workLocal area- Global Lead, Medical Intelligence to Strategy Location: Cambridge, MA, Morristown, NJ At Sanofi, we chase the miracles of science to improve... .... Champion Medical Plai and other predictive analytics platforms, overseeing their design, testing, and integration into Medical...PlatformShift work
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...SSIM) – formerly State Street Global Advisors (SSGA) – is seeking... ...across SSIM globally. You will lead global teams responsible for... ...AI, and enterprise‑scale AI platforms – ensuring alignment with GTS... ...stringent risk, security, and regulatory requirements; ensure robust...PlatformRegulatoryTemporary work$172.5k - $222.5k
...Senior Manager, Global Risk Management, Enterprise Fraud Risk... ...) is one of the world's leading internet financial platform companies, building the foundation... ...managed in line with regulatory obligations, enterprise... ...is determined by various factors, including but not limited...PlatformRegulatoryLocal areaFlexible hours- ...Fullscript We’re an industry-leading health technology company on... ...That simple idea grew into a platform that powers every part of care... ...that make care smarter and more human. Tools that save time,... ...AI, product development, and regulatory compliance, partnering closely...PlatformRegulatory
$130k - $170k
...Incident Response Lead At WHOOP, we're on a mission to unlock human performance and healthspan.... ...impact assessments and regulatory notification processes... ...on expertise with SIEM platforms, EDR tools, and cloud security... ...pay is based on factors such as job-related skills...PlatformRegulatoryFull timeWork at officeRelocation$148.5k - $214.5k
...Sciences department within Sanofi R&D Global CMC Development organization has... ...roles and responsibilities in leading the preparation of CMC dossiers for regulatory submissions to enable advancement... ...Experience with data integration platforms. Understanding of AI/ML...PlatformRegulatory- ...novel micro-array patch platform. With only five... ...chemistry, biology, and human factors to address important unmet... ..., biotech, medical device or pharmaceutical manufacturing... ...and compliance with regulatory standards Supports... ...to positively impact global human health Vaxess is...PlatformRegulatory
- ...highly collaborative Vice President & Global Head of Communications to lead our global communications function.... ...the company’s communications platform and messaging to align with the company... ..., Patient Advocacy, Marketing, Regulatory, Compliance et al to ensure messaging...PlatformRegulatory
- ...Description The Lead Business Analyst is a senior individual contributor within the... ...implementation and optimization of main platforms (e.g., payment gateways, billing systems... ...solutions align with enterprise architecture, regulatory requirements, and financial controls...PlatformRegulatoryFull timeWork at officeLocal areaRelocation package
$196.7k - $353.4k
...Individual will be responsible for leading our global payroll function, including... ...countries with varying regulatory, tax, and employment... ...the implementation of new platforms, optimization of existing systems... ...will be based on several factors including, but not limited...PlatformRegulatoryLocal area$201.37k - $236.9k
...build the emerging onchain platform — and with it, the future global financial system. To... ...Software, and Operating Cash Lead cross-functional... ...tools evolve, and apply human-in-the-loop practices to... ...bank, fin-tech, financial regulatory agency and/or professional...PlatformRegulatoryLocal area$238k - $374k
...AIRx Biologics Program Lead Takeda Research is constructing... ...computational and experimental platforms Partner with Clinical and... ...strong business acumen including regulatory (BLA/MAA pathway) and... ...compensation is an important factor as you consider the next step...PlatformRegulatoryMinimum wageTemporary workLocal areaRemote work$140k - $185k
...Lead KYC Utility Analyst Circle (NYSE: CRCL) is... ...leading internet financial platform companies, building the... ...of a more open, global economy through digital... ...ensure compliance with regulatory expectations. Recommending... ...determined by various factors, including but not...PlatformRegulatoryRemote workFlexible hours$200k - $275k
...269**About Analog Devices**Analog Devices, Inc... ...NASDAQ: ADI) is a global semiconductor... ...reliably connect humans and the world, and... ...Heterogenues AI Accelerator Lead**Boston, MA; San... ...Synopsys Platform Architect to translate... ...or other bona fide factors.* This position qualifies...PlatformPermanent employmentWork at officeDay shift- ...in 1977, GMO is a global investment manager... ...bubbles and also as a leading climate investor... ..., and regulatory requirements, with... ...private banks, and platform partners; Partner... ...for a wide array of factors that are considered... ...but do not replace human judgment. Final hiring...PlatformRegulatoryLocal areaWorldwideFlexible hours
$130k - $209k
...Job Title Sr Global Product Manager, MCT... ...software/hardware platform. Your role:... ...market trends and regulatory requirements. Continuously... .... Medical Device experience is required... ...belief that every human matters, and we... ...depending on multiple factors including job-...PlatformRegulatoryFull timeWork experience placementWork at officeLocal areaImmediate startWork visaRelocation package3 days per week
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