Global Submissions Lead, Regulatory Strategy
Vertex Pharmaceuticals Inc (US)
Vertex Pharmaceuticals Inc (US) is seeking an Associate Director for Global Submission Management to oversee strategic global regulatory submissions across development and lifecycle programs, with emphasis on Pulmonary or Cell & Gene Therapy areas. You will ensure timely, compliant, and predictably delivered submissions aligned with global regulatory strategies. The role leads cross‑functional teams, manages submission plans, and drives continuous improvement using advanced tools including #J-18808-Ljbffr Vertex Pharmaceuticals Inc (US)
$177k - $278.08k
Takeda is seeking a Director, Global Regulatory Lead Oncology to oversee regulatory activities for oncology programs in Boston, MA. This role involves managing FDA submissions and setting global regulatory strategies. Ideal candidates will have 8+ years of pharmaceutical...Regulatory$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- ...Inc. in the United States is seeking a Global Submission Manager to oversee global submission... ...portfolio. You will represent GRO on Global Regulatory Teams, coordinate submission planning,... ...Associates, drive digital submission strategies, and act as SME during audits and...Regulatory
- ...Pharmaceuticals in Boston is seeking a Regulatory Strategy Associate Director responsible for overseeing global and regional regulatory... ...with major health authority submissions. This role offers the... ...potential bonuses, and market-leading benefits. #J-18808-Ljbffr Vertex...Regulatory
- Job title: Global Regulatory Strategist Location: Morristown, NJ/ Cambridge, MA... ...developing regulatory product strategies for the oncology therapeutic area, leading regulatory efforts in the development... ...remit, as needed Regulatory Submissions & Operations Leads submission...RegulatoryLocal area
- Mass Digital Health is seeking a Global Regulatory Lead to develop and execute innovative regulatory strategies across its product portfolio. Based in either Morristown, NJ, or Cambridge, MA, this role is vital to ensure compliance with industry standards while advocating...Regulatory
- Medella Life is looking for a Director of Regulatory Affairs to spearhead regulatory strategy for rare disease programs in Cambridge, MA. This role involves leading regulatory submissions and acting as the primary interface with health authorities like the FDA. The ideal...Regulatory
- Allergan is seeking a Director of Regulatory Affairs to develop and implement global regulatory strategies to secure product approvals. The role involves leading the Global Regulatory Product Team and requires strong leadership experience within the pharmaceutical sector...Regulatory
- A leading pharmaceutical company is looking for a Director of Regulatory Affairs to provide strategic and operational leadership in... ...candidate will prepare regulatory submissions, interact with health... ...vital for supporting ongoing global clinical studies. #J-18808-Ljbffr...Regulatory
- Takeda is seeking an experienced Regulatory CMC Leader in Boston to independently develop regulatory CMC strategy and lead regulatory submissions across the product lifecycle. You will partner with regulatory, development, and commercial teams to drive compliant, timely...Regulatory
$177k - $278.08k
JobRx, Inc. is seeking a Regulatory Affairs professional in Boston, MA to manage regulatory CMC strategy for pharmaceutical products. The role requires 10+ years of experience with a strong focus on leading major submissions and ensuring regulatory compliance. This position...Regulatory- Job Description OBJECTIVES/PURPOSE Lead development and advancement of Global Patient Access (GPA) strategies across programs, ensuring alignment with enterprise priorities, regulatory requirements, and product lifecycle needs Drive data‑driven and technology‑enabled...RegulatoryFull timeLocal areaNight shift
$154.4k - $242.55k
...future for the world. As a global, values‑based... ...Global Risk Financing Strategy and ensuring alignment... ...overall group strategy. Lead specific Global Insurance... ...of underwriting submissions and support any market... ...business challenges and/or regulatory issues; recommend...RegulatoryMinimum wageFull timeContract workTemporary workWork at officeLocal areaImmediate start- A biopharmaceutical company in Boston is seeking a Regulatory Affairs Specialist to coordinate the preparation of regulatory submission packages. The ideal candidate will have at least 8 years of experience in Regulatory Affairs, particularly with Small Molecule drugs,...Regulatory
- ...for a Senior Director and Regulatory Platform Lead in Boston, MA, to lead the... ...of innovative regulatory strategies for device and drug-device... ...Human Factors, regulatory submissions, and cross-functional collaboration... ..., interfacing with global health authorities, and...Regulatory
- Sanofi is seeking a Global Regulatory Lead to shape and execute innovative regulatory strategies for oncology products. This role interfaces with various teams to ensure compliance and strategic alignment, reporting directly to senior management. The ideal candidate will...Regulatory
$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 of... ...scientific platforms and AI-generated content meet regulatory, medical-legal-regulatory (MLR) review, and...RegulatoryFull time- ...Therapeutics, Inc. in Watertown, Massachusetts is seeking a Vice President or Senior Vice President of Regulatory Affairs. This role leads global regulatory strategies for the oncology pipeline and ensures compliance with regulatory requirements. The ideal candidate...Regulatory
$208.2k - $327.14k
A leading global R&D organization is seeking a Senior Director, Global Regulatory Lead - Oncology. This role involves leading global regulatory strategy and engaging with cross-functional teams to ensure... ...background in regulatory submissions. The position is based in...Regulatory- ...thing. Position Summary You will lead Chemistry, Manufacturing, and Controls (CMC) regulatory strategy and execution for mature... ...compliance with FDA expectations and global standards. Prepare and review... ..., with a focus on IND and BLA submissions to the FDA. Experience as a...RegulatoryLocal area
- Job title: Global Regulatory Lead Location: Morristown, NJ / Cambridge, MA About The Job As the Global... ..., and robust global regulatory strategies for their products in Sanofi’s diversified... ...Project Strategy (GRPS), Global Submission Strategy, and core product labeling in...Regulatory
- Takeda is seeking a Senior Director, Global Regulatory Lead for Oncology in Boston, MA. This role involves leading global regulatory strategy for complex oncology projects, with responsibilities... ...that include overseeing FDA submissions and ensuring compliance with...Regulatory
$245k - $300k
...Biosciences in Cambridge, MA is seeking a Sr. Director, Regulatory Affairs to lead and execute global regulatory strategies. The ideal candidate will oversee health authority interactions, regulatory submissions, and strategic guidance for innovative therapeutics. Key...Regulatory$238k - $374k
...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... ...a proven track record in managing submissions and aligning cross-functional teams....Regulatory- ...Therapeutics, Inc is seeking a Director of Regulatory Affairs based in Boston. This... ...developing and executing regulatory strategies to support global product development, particularly in... ...and the ability to manage regulatory submissions and work with health authorities...Regulatory
$137k - $215.27k
BioSpace is seeking a Manager Regulatory Lead in Boston, MA, accountable for implementing regulatory strategies and coordinating life cycle... ...a background in regulatory submissions and FDA interactions. This role... ...involves collaboration with global and local regulatory teams,...RegulatoryLocal area$212k - $333.19k
Takeda is seeking a Senior Director to define and lead global regulatory strategies in Boston, MA. This role requires over 12 years of experience... ...pharmaceutical industry, with a strong emphasis on regulatory submissions and compliance. The ideal candidate will have proven...Regulatory- ...Pharmaceuticals Inc is seeking a Director, Global Submission Management (GSM) to provide strategic oversight and execution of global regulatory submissions across development and... ...submissions aligned with global regulatory strategies. It requires leadership across...Regulatory
$150k - $200k
A biopharmaceutical company is seeking a Medical Writing Lead to oversee the creation of clinical documents across drug development... ...over 7 years of medical writing experience and expertise in regulatory submissions. This hybrid role allows employees to work from Cambridge,...Regulatory$137k - $215.27k
..., Inc. is seeking a Manager Regulatory Lead based in Boston, MA to oversee and implement regulatory strategies for plasma-derived therapies... ...role involves coordinating the Global Regulatory Team, ensuring... ...requirements, and managing submissions across international regions...Regulatory
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Global Submissions Lead, Regulatory Strategy. Be the first to apply!

