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
- 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
- ...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
$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$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- ...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
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...Summary: The Executive Director, Global Value Evidence Lead, is a strategic leader responsible for... ...evidence generation initiatives to support regulatory, HTA, and payer submissions, and... ...Familiarity with innovative evidence platforms, digital health technologies, and...PlatformRegulatoryTemporary workLocal areaFlexible hours- 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
- ...deliver your best. As part of the Global Medical Affairs Oncology team... ...Communications Group Lead, Solid Tumors. About the role... ...development of the scientific platform for assigned assets to provide... ...publication planning. Compliance and Regulatory - excellent understanding of...PlatformRegulatoryFor contractorsWork experience placementFreelanceLocal area
$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$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- 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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Initial Therapeutics, Inc. is looking for a professional in Boston, MA, to contribute to Global Regulatory Affairs CMC. The role requires 6+ years of regulatory CMC or Device experience and a BS/BA degree in a scientific discipline. Responsibilities include executing regulatory...Regulatory$238k - $374k
JobRx, Inc. is seeking an Executive Director of Global Regulatory Affairs in Boston, MA. This leadership role requires over 20 years of industry... ...significant expertise in regulatory submissions for medical devices and combination products. You will oversee a team to develop...Regulatory- Takeda is looking for an experienced regulatory affairs professional to develop and lead global regulatory strategies for precision medicine and digital health... ...in regulatory affairs, particularly with medical devices and diagnostics. The ideal candidate will have a strong...RegulatoryRemote work
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...You will be a member of the Global Labeling, Global Regulatory Affairs team and will lead all Labeling activities required... ...the role will depend on several factors, including responsibilities of... ...Programs ~ Wellbeing Incentive Platforms & Incentives ~ Professional Development...PlatformRegulatoryHourly payWork experience placementLocal areaRemote workWorldwide$188k - $258.5k
Purpose of the Role To lead and coordinate... ...strong emphasis on human factors integration and regulatory readiness. Roles and... ...Facilitate alignment of device strategy across multiple... .... Familiarity with global regulatory... ...with auto‑injector platforms (e.g., YpsoMate) is...PlatformRegulatoryTemporary work- ...preclinical validation of our innovative neuromodulation platform. This role involves designing studies to showcase the efficacy and safety of our device. You'll collaborate with experts, contributing to regulatory submissions and clinical trials. Your expertise in...PlatformRegulatory
$20k
...for each vendor and software platforms. This includes main campus and... ..., radiologists, CT Division lead radiologists to ensure exam protocols... .... -Assist in oversite of regulatory requirements pertaining to CT... ...(34-66%) 35lbs+ (w/assisted device) Carrying Frequently (34-6...PlatformRegulatoryWork at officeRelocation package$131.9k - $161.2k
...Manager, Medical Devices As the Quality System... ...Devices, you will lead the design,... ...accountable for ensuring regulatory compliance while... ...Own and evolve the global Medical Devices... ...existing workflows and platforms (e.g., PLM, Veeva,... ...0 - $161,200 USD. Factors which may affect...PlatformRegulatoryTemporary workLocal areaFlexible hours$19.72 - $29.3 per hour
...POSITION SUMMARY: The Lead Emergency Technician... ...and maintain medical devices such as stretchers,... ...Compliance - Awareness of regulatory standards (e.g., HIPPA... ...and a broad range of factors is considered when... ...messages or social media platforms. We do not ask...PlatformRegulatoryFull timeContract workFixed term contractImmediate startFlexible hours- Monte Rosa Therapeutics is seeking a Regulatory Operations Manager in Boston, MA. This role demands... ...databases, maintain compliance with global standards, and prepare submission-ready... ...documents. The position offers an opportunity to lead cross-functional teams and contribute to...Regulatory
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...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 workRelocation packageShift work$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- A leading life sciences company is seeking a Senior Regulatory Affairs Manager to lead their dynamic team through global clinical trials. The role involves driving submission planning, ensuring compliance with regulatory authorities, and managing multiple priorities. Candidates...RegulatoryRemote job
$212k - $333.19k
...impact on patients worldwide. Join Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you will be part of the global regulatory... ...Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are...RegulatoryMinimum wageTemporary workLocal areaWorldwide
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