Global Regulatory Strategy Lead — AI-Driven Drug Development
Isomorphiclabs
Isomorphic Labs in Cambridge, MA seeks a Senior Head of Global Regulatory Affairs and Strategy to build the regulatory function from IND/CTA through NDA/BLA/MAA. You’ll design systems for GxP, PV, and Medical Writing, leveraging AI to speed regulatory decisions and approvals. You will partner with R&D, QA, and external vendors to align strategy and execution. This is a high-impact leadership role driving global regulatory capabilities in a fast-paced, innovative biotech startup environment. #J-18808-Ljbffr Isomorphiclabs
- ...market innovative drugs across our main therapeutic... ...better. Chiesi Global Rare... ...focused on research, development and commercialization... ...Access Marketing, Strategy, & US HEOR for the... ...Americas, this role will lead the development... ...(Legal/Medical/Regulatory) and experience with...RegulatoryHourly payWork at officeLocal areaRemote workRelocation packageFlexible hours
$154.4k - $242.55k
...focused, innovation-driven company to... ...shine? Join us as Global Biomarker Lead, Inflammation, GI... ...for the development and implementation... ...translational biomarker strategies across... ...mechanism of action and drug response.Lead... ...documents submitted to Regulatory Agencies.•...RegulatoryMinimum wageTemporary workLocal area$206.25k - $297.92k
Job title: Global Lead, Scientific Platforms &... ...our Take the Lead strategy to become more... ...way to immersive, AI-powered, personalized... ...’re an R&D-driven, AI-powered biopharma... ...content meet regulatory, medical-legal-regulatory... ...early in drug development and uses their insights...RegulatoryFull time- Sanofi is seeking a Global Patient Activation Director in Cambridge, MA to lead the activation strategy for Rare Diseases and drive patient-centric programs across global... ...improve access to treatments, while ensuring regulatory compliance and cross-functional...Regulatory
- Takeda Clinical Development in Cambridge, MA is seeking... ...a senior role to lead development and advancement of Global Patient Access (GPA) strategies across programs, ensuring... ...alignment with regulatory requirements and product... ...emphasizes data-driven design, use of digital...Regulatory
$212k - $333.19k
...Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug‑Device... ...leadership for the development and implementation... ...product regulatory strategies particularly pertaining... ...implementation. Globally influence and serve... ...science‑based, data‑driven regulatory positions...RegulatoryMinimum wageFull timeTemporary workLocal areaWorldwideNight shift$177k - $278.08k
...Join Takeda as a Director, Global Regulatory Lead Oncology where you will be... ...will set global regulatory strategy and lead major submissions... ...multiple complex projects in development and/or supports regulatory... ...Solid working knowledge of drug development process and regulatory...RegulatoryMinimum wageTemporary workLocal areaRemote workWorldwide$178.1k - $244.86k
...OBJECTIVES/PURPOSELead development and advancement of Global Patient Access (GPA) strategies across programs,... ...enterprise priorities, regulatory requirements, and product... ...lifecycle needsDrive data-driven and technology-enabled... ...Lead end-to-end strategy development...RegulatoryMinimum wageTemporary workLocal areaNight shift$192.4k - $302.39k
...focused, innovation-driven company that will... ...? Join us as a Global Medical Lead, Nephrology in... ...and global brand strategy. This includes incorporating... ..., Commercial, Regulatory, PV, Health... ...expert and lead the development and dissemination... ....Leveraging AI, machine learning...RegulatoryMinimum wageTemporary workWork at officeLocal areaRemote work$148.5k - $214.5k
...Industrialization Leader, Drug Product... ...Lead ensures that drug... ...projects from Phase 2 Development to TT Kickoff,... ...Sanofi:We’re an R&D-driven, AI-powered... ...CMC development strategy for DPEnsure process... ...of experience Regulatory CMC, Process /... ...and a resilient global supply.Power industry...RegulatoryFull timeContract workWorldwide- Noema Pharma in Watertown, MA is seeking a Director of Regulatory Affairs to lead regulatory strategy and oversight for multiple development programs, from IND through potential NDA/MAA submissions, and to guide cross-functional teams toward compliant execution. The ideal...Regulatory
$232.5k - $335.83k
Job Title: Global Brand Lead, Transplant (Solid Organ... ...in later-stage development with potential launches... ...area, strategy, P&L, and market,... ...Affairs, Digital, Regulatory, and regional commercial... ...including AI-powered toolsAbout... ...and deliveryData-Driven Decision Making and...RegulatoryFull timeLocal area- AbbVie is seeking a Director Regulatory Affairs Global Regulatory Lead (GRL II) in Cambridge, MA. This role... ...developing and implementing global strategies for product approvals while... ...including strategic leadership and drug development in complex environments. Benefits...Regulatory
- Moderna seeks a Global Medical Director to lead medical affairs strategy across our Oncology portfolio, spanning early development through commercialization. This role emphasizes external... ...functional alignment, interfacing with regulatory, clinical, and commercial functions....Regulatory
$206.25k - $297.92k
Job title: Global Lead, Medical Intelligence to... ...our Take the Lead strategy to become more focused... ...intelligence (AI), Generative AI, and... ...pioneering data-driven capabilities that... ...generation plans.Lead the development and optimization... ...patients early in drug development and...Full timeShift work- ...Therapies (PDT) R&D Organization in Cambridge, MA is seeking a Global Regulatory Labeling Strategy Lead (Associate Director) to steer labeling strategy across... ...Commercial teams to shape labeling for pharmaceutical drugs and devices and ensure alignment with Health Authority...Regulatory
- ...Sanofi is seeking a Global Medical Director for Rare Hematology in Cambridge, MA. This medical lead oversees global medical strategy, alignment across clinical development, HEVA, regulatory, and market access to drive evidence generation and publications. The role requires...Regulatory
$232.5k - $335.83k
...title: Head of Strategy and Management Office, Global Clinical... ...Global Clinical Development team, you'll lead the transformation... ...meets bold, AI-powered research... ...We're an R&D-driven, AI-powered biopharma... ...internal and regulatory audit... ...patients early in drug development...RegulatoryFull timeWork at office$238k - $374k
....As Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Product... ...leadership and development to global regulatory subject... ...innovative and robust regulatory strategies for medical devices and... ...How you will contribute:Leads and develops a team of...RegulatoryMinimum wageTemporary workWork at officeLocal areaRemote workWorldwide- .... is seeking a senior leader to own the Global Product Ownership model for BioLife. You... ...and devices, and guide product vision, strategy, and prioritization across donor experience... ...will connect frontline operations with regulatory, quality, and digital delivery teams,...Regulatory
$100k - $143k
...Massachusetts is looking for a motivated regulatory professional to join their... ...this role, you will support the development and execution of regulatory strategies for a transformative pipeline, contributing... ...experience, and knowledge in drug development processes. The...Regulatory$202.4k - $265.7k
...looking for a RWE Strategy Lead Developed Brands... ...will lead the development and execution of global real-world evidence... ...that inform regulatory, market access,... ...-term outcomes, drug utilization, safety... ..., including AI-enabled approaches... ...by patients and driven by science. Why...RegulatoryPermanent employmentContract workWork at officeLocal area$178.5k - $257.83k
Job Title: Lead, US Hematology Pipeline... ...pioneered the development and delivery of... ...with the global patient community... ...US commercial strategy, market development... ...: We’re an R&D-driven, AI-powered... ...understanding of the drug development process... ...clinical, regulatory, medical, access...RegulatoryFull time$178.5k - $257.83k
Job title: Global Lead, Innovation Expansion... ...Take the Lead strategy to become more... ...immunoscience meets bold, AI-powered... ...’re an R&D-driven, AI-powered biopharma... ....Lead the development and management... ...market contexts, regulatory requirements,... ...patients early in drug development and...RegulatoryPermanent employmentFull timeLocal areaWorldwide$192.4k - $302.39k
...focused, innovation-driven company that... ...Join us as a Global Medical Lead, PDT... ...Hematology GM strategy in close collaboration... ...and lead development global medical... ...Quality, Safety, Regulatory, Manufacturing... ...and incorporate AI-driven... ...environment (eg. drug development and...RegulatoryMinimum wageTemporary workWork experience placementWork at officeLocal areaRemote work$206.25k - $297.92k
Job title: Global Lead, Health Ecosystem &... ...Take the Lead strategy to become more... ...immunoscience meets bold, AI-powered... ...’re an R&D-driven, AI-powered biopharma... ...therapeutics regulatory landscape,... ...Affairs, Business Development, Digital Health... ...patients early in drug development and...RegulatoryFull time- ...to speed up drug discovery and development to find answers... ...tools and AI‑powered solutions... ...We’re an R&D‑driven, AI‑powered... ...Responsibilities Lead, coordinate,... ...dossier strategy and CMC activities... ...dossier for regulatory submissions (... ...of people globally by making drug...Regulatory
$177k - $308k
...the world. We are a global healthcare leader... ...innovation-based strategy to discover, develop... ...model-informed drug development approaches through strategic AI and automation adoption... ...Strategy Lead who will define and... ...scientific rigor, regulatory defensibility, and...RegulatoryFull timeFlexible hours$167k - $300.7k
...seeking a Director of Regulatory Strategy to support select programs... ...leader within Global Regulatory Science, responsible... ...with therapeutics development is preferred. Here’s... ...as global regulatory lead accountable for all regulatory... ...and legislation for drug development, product...RegulatoryPermanent employmentWork at office$151.75k - $227.63k
Reporting to VP Global Head Patient Experience... ...responsible for leading the Global patient advocacy strategy and patient... ...Advance patient-focused drug development, ensuring strategic... ..., legal, regulatory and other issues that... ...where every day is driven by the needs of people...RegulatoryFull timeTemporary workWork at officeLocal areaFlexible hours3 days per week
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Global Regulatory Strategy Lead — AI-Driven Drug Development. Be the first to apply!
- food regulatory Cambridge, MA
- regulatory contract Cambridge, MA
- regulatory cmc Cambridge, MA
- regulatory Cambridge, MA
- regulatory scientist Cambridge, MA
- regulatory law Cambridge, MA
- clinical research regulatory Cambridge, MA
- regulatory accountant Cambridge, MA
- regulatory executive Cambridge, MA
- regulatory technician Cambridge, MA


