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
$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- 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- Global Atopic Dermatitis Medical Lead Location: Cambridge, MA / Morristown, NJ About the... ...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- Objectives/Purpose The Global Medical Communications Lead, Dermatology is a key strategic... ...scientific communication platform and core communication... ...Familiarity with international regulatory and legal guidelines... ...compensation is an important factor as you consider the next step...PlatformRegulatoryRemote work
- ...for defining and executing the global strategy for tuning,... ...operational efficiency, and regulatory defensibility. Position Responsibilities... ...analytics strategy into platform, data, and operating model decisions... ...Rulebook Optimization Lead the ongoing optimization of global...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
$167k - $300.7k
...oncology, we are seeking a Global Competitive Intelligence Lead - Oncology to lead... ...pipelines, clinical trial data, regulatory strategies, commercial... ...Familiarity with AI‑driven CI platforms, digital dashboards, and... ...will be based on several factors including, but not...PlatformRegulatory$128.55k - $222.82k
...for defining and executing the global strategy for tuning,... ...operational efficiency, and regulatory defensibility. Position Responsibilities... ...analytics strategy into platform, data, and operating model decisions... ...Rulebook Optimization Lead the ongoing optimization of global...PlatformRegulatoryLocal areaFlexible hours$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- 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
- Job title: Global Lead, Health Ecosystem & Innovation Location: Cambridge, MA, Morristown... ...Therapeutics (DTx) companies, patient-finding platforms, and innovation accelerators that bring... ...on the evolving digital therapeutics regulatory landscape, patient data governance...PlatformRegulatory
$245.45k - $381.11k
Position Summary: The Executive Director, Global Value Evidence Lead, is a strategic leader responsible... ...generation initiatives to support regulatory, HTA, and payer submissions, and demonstrate... ...Familiarity with innovative evidence platforms, digital health technologies, and...PlatformRegulatoryTemporary workLocal areaFlexible hours$147k - $212k
...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$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- Cure Talent is partnering with a global medical device company to hire a Regulatory Affairs Lead in the United Kingdom. The role is hands‑on and senior IC within a three‑person team, covering EU MDR, US FDA submissions, and global registrations. You will review Technical...Regulatory
- 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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$158.6k - $285.5k
...Associate Director to lead the design,... ...solutions spanning non‑human identity (NHI) and... ...deploy enterprise platforms for secrets... ...distribution, and device management concepts... ...days, sabbatical, global recharge days, and... ...nature of the work and regulatory requirements, only...PlatformRegulatoryPermanent employmentTemporary workLocal area- ...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
$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- Carda Life Sciences is seeking a Regulatory Affairs Manager to lead global regulatory efforts for a well-known medical device manufacturer. The successful candidate will create and implement strategies to achieve regulatory approvals and manage teams across different departments...Regulatory
$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- ...Global Trade Compliance Director At Boston Scientific... ...that supports regulatory compliance, enterprise... ...regulatory engagements. Lead global customs, import... ...compliance technology platforms, including SAP GTS, automation... ..., such as medical device, pharmaceutical, aerospace...PlatformRegulatoryWork at officeLocal areaRelocation package3 days per week
- ...define and execute the vision for safety-platforms including Argus, Veeva Safety Docs,... ...to enhance safety submissions and regulatory compliance. You will lead cross-functional teams, drive... ...strategies across PSPV, aligning with global regulations and business goals. #J-...PlatformRegulatory
- Job title: GRA Device Associate - Medical Devices and Combination... ..., NJ About The Job The Global Regulatory Affairs (GRA) Device team is... ...combination with a drug product, leading regulatory efforts in the... ...‑edge AI, data, and digital platforms to push the boundaries of science...PlatformRegulatoryLocal areaWorldwide
$47 - $67.74 per hour
...for each vendor and software platforms. Assimilates any new CT scanning... ..., radiologists, CT Division lead radiologists to ensure exam... .... Assist in oversite of regulatory requirements pertaining to CT... ...(34-66%) 35lbs+ (w/assisted device) Carrying Frequently (34-6...PlatformRegulatoryHourly payWork at officeRemote workShift work- SoTalent seeks a Senior Manager, Global Regulatory Affairs (CMC) to drive regulatory strategy and submissions for clinical development and post-approval. The role collaborates with development, QA, analytical, and manufacturing teams, ensuring alignment with global requirements...Regulatory
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