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
- ...for a Senior Director and Regulatory Platform Lead in Boston, MA, to lead the... ...regulatory strategies for device and drug-device combinations... ...with a strong emphasis on Human Factors, regulatory submissions, and... ...strategies, interfacing with global health authorities, and ensuring...PlatformRegulatory
- ...seeking a Senior Director and Regulatory Platform Lead in Boston, MA to provide... ...for combination products and devices. The candidate will develop... ...strategies with a focus on Human Factors, ensuring compliance with... ...reports, and deep knowledge of global regulatory processes....PlatformRegulatory
- Responsibilities Lead development and implementation of regulatory strategies for pure device and drug-device combination products with a focus on Human Factors across development, registration, commercialization... ...subject matter expert for global Human Factors regulation for...PlatformRegulatoryNight shift
$212k - $333.19k
...worldwide. About the role As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug‑Device Combinations Human Factors, you will provide leadership for the... ...prospective and proactive implementation. Globally influences and serves as a key opinion leader...PlatformRegulatoryFull timeTemporary workLocal areaWorldwideNight shift- Takeda is seeking a Senior Director and Regulatory Platform Lead in Boston to develop innovative... ...for combination products, focusing on Human Factors. This role demands over 10 years of industry... ...teams and lead interactions with global health authorities, ensuring...PlatformRegulatory
$238k - $374k
Initial Therapeutics, Inc. is looking for an Executive Director of Global Regulatory Affairs in Boston, MA. This role entails leading a team to oversee the regulatory strategy for medical devices and drug-device combination products. The successful candidate will have...Regulatory$237.2k - $372.79k
...Description Join us as a Global Medical Lead, Dermatology in our Cambridge... ..., market access, and regulatory strategies, leads cross‑functional... ...Utilizes digital tools and platforms to share and update medical... ..., mobile apps, wearable devices, and digital therapeutics....PlatformRegulatoryTemporary workWork at officeLocal areaWeekend work- ...Global Atopic Dermatitis Medical Lead Location: Cambridge, MA / Morristown, NJ Join... ...the highest ethical, regulatory, and scientific standards... ...strategy both for product and device development as well as... ..., and interactive online platforms to reach a broader audience...PlatformRegulatoryWorldwide
$167k - $300.7k
The Role Global Competitive Intelligence Lead‑Oncology - responsible for developing and executing Moderna’s... ...competitor pipelines, clinical trial data, regulatory strategies, commercial activities,... .... Experience with AI‑driven CI platforms, digital dashboards, and foresight...PlatformRegulatory- Job Description OBJECTIVES/PURPOSE Lead development and advancement of Global Patient Access (GPA) strategies... ...alignment with enterprise priorities, regulatory requirements, and product... ...strategy development, leveraging digital platforms, analytics, and insights to...PlatformRegulatoryFull timeLocal areaNight shift
$177k - $278.08k
Global Product Strategy Group - Overview The Global Product Strategy... ...TAK-279 into the PsA market. Lead key differentiation... ...materials, including messaging platform, campaign assets, brand book,... ...navigates cross‑cultural and regulatory considerations. Education & Required...PlatformRegulatoryTemporary workWork at officeLocal area$167k - $300.7k
...oncology, we are seeking a Global Competitive Intelligence Lead-Oncology to lead Moderna’... ..., clinical trial data, regulatory strategies, commercial activities... ...with AI‑driven CI platforms, digital dashboards, and... ...will be based on several factors including, but not limited...PlatformRegulatoryWork from home- Medical Affairs Lead, Global Rare Diseases - Contractor Department: GRD Global Medical Affairs... ...development strategies. Vendor and Platform Oversight: Manage learning tools and digital... ...-affiliate teams. Familiarity with regulatory and compliance requirements for...PlatformRegulatoryContract workTemporary workFor contractorsLocal area
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Job title: Global Lead, Innovation Expansion & Adoption Location: Cambridge, MA, Morristown... ...roadmaps for major Medical Innovation platforms, ensuring solutions are configured, deployed... ...are adapted for local market contexts, regulatory requirements, and operational...PlatformRegulatoryPermanent employmentFull timeLocal areaWorldwide$169.4k - $266.2k
...your best. As part of the Global Medical Affairs... ...Scientific Communications Group Lead, Solid Tumors. As a... ...of the scientific platform for the assigned assets... ...analyses. Compliance and Regulatory: Excellent understanding... ...depend on a variety of factors, including the qualifications...PlatformRegulatoryMinimum wageFull timeFor contractorsWork experience placementFreelanceLocal areaRemote work$206.25k - $297.92k
Job title: Global Lead, Scientific Platforms & Engagement Strategy Location: Cambridge, MA, Morristown, NJ About the Job At Sanofi, we chase the miracles... ...all scientific platforms and AI-generated content meet regulatory, medical-legal-regulatory (MLR) review, and ethical...PlatformRegulatoryFull time$238k - $374k
...worldwide. As Executive Director, Global Regulatory Affairs CMC Devices and Drug‑Device Combination Product... ...China). How you will contribute Lead and develop a team of regulatory leaders... ...evidence generation, usability/human factors, risk management, and value messaging...RegulatoryMinimum wageFull timeTemporary workWork at officeLocal areaRemote workWorldwide- ...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
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...Job Title: GRA Device Lead (Associate Director) Location: Cambridge, MA/ Morristown... ...our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally... ...Leverage advanced AI, data, and digital platforms to push the boundaries of...PlatformRegulatoryTemporary workLocal areaWorldwideFlexible hours$142.73k - $237.88k
The Device Lead of Global MSAT Drug Delivery and Aseptic Technology... ...owner of the Device platform and be globally... ...including post-approval regulatory change management, continued... ...account a number of factors including work... ...general procurement/human resources department...PlatformRegulatoryFull timeLocal area- Scorpion Therapeutics is seeking a Regulatory Strategy Lead in Boston, MA. This role involves developing... ...regulatory strategies focusing on Human Factors for devices and drug-device combinations. The... ..., and ensuring compliance with global standards. Join us to shape future...PlatformRegulatory
$216k - $324k
...Immunology (R&I) as a Global Product Leader (GPL) for... ...into the process. As the lead ambassador for the... ...safety and efficacy for regulatory approval plus value for... ...multiple individualized factors, including market location... ...working gives us the platform we need to connect, work...PlatformRegulatoryTemporary workWork at officeFlexible hours3 days per week- ...Senior Faculty Lead, Digital Pathology Infrastructure and AI... ..., and success metrics. Platform Build and Integration ~ Lead... ...readiness for applicable regulatory and accreditation requirements... ...validation, workflow redesign, QC, human factors, AI evaluation literacy, and...PlatformRegulatoryPart timeTraineeshipWork from home
$150k - $200k
...NYSE/TSX: BLCO) is a leading global eye health company dedicated... ...Fellow - Medical Device Toxicologist will... ...activities, and with key regulatory expectations and... ...depend on a variety of factors. U.S. based employees... ...and social media platforms. To learn more please...PlatformRegulatoryTemporary workRemote workWork visa$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- Biogen, Inc. is seeking a Head of Quality for Device and Combination Products to lead global quality strategy at our Cambridge, MA headquarters. The role... ...requires a visionary leader to ensure compliance with regulatory standards, oversee quality management, and support...Regulatory
$110k - $125k
...clinical studies focusing on solid organ platforms. This role involves data management,... ...operations, and ensuring compliance with regulatory standards. The candidate should have at... ...research, preferably within the medical device or pharmaceutical industry. The position...PlatformRegulatoryRemote job$130k - $230k
Lead Clinical Data Management, ClinicalData Management... ...development decisions, regulatory submissions, and... ...technologies, automation platforms, and advanced analytics... ...their application within global development programs.... ...manufacture, and market human and veterinary pharmaceuticals...PlatformRegulatoryImmediate start$20k
...vendor and software platforms. This includes... ...radiologists, CT Division lead radiologists to... ...in oversite of regulatory requirements pertaining... ...5lbs+ (w/assisted device)Carrying... ...and other essential factors. The base pay information... ...may contact Human Resources at (857)...PlatformRegulatoryWork at officeRemote workRelocation package$153.6k - $241.34k
A leading pharmaceutical company is seeking an Associate Director to define and lead global regulatory strategies. This role requires significant experience in regulatory affairs and offers opportunities for strategic leadership across multiple projects. Located in Boston...Regulatory
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