Global Regulatory Strategy Lead - Shape Submissions
$196.8k - $295.2kVertex Pharmaceuticals
Vertex Pharmaceuticals Inc (US) is seeking a Regulatory Strategy Director in Boston, MA. In this role, you will lead the development and implementation of global regulatory strategies for assigned projects. The successful candidate will have a Bachelor's degree in Biology or Chemistry and typically requires 10 years of pharmaceutical regulatory affairs experience. A competitive pay range of $196,800 - $295,200 is offered, with contributions to innovative regulatory solutions and team leadership emphasized. Join Vertex and help shape vital healthcare strategies. #J-18808-Ljbffr
$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- Sanofi is seeking a Global Submission Lead to manage regulatory submission activities for new global products. The role involves project management, ensuring compliance with regulatory standards, and leading cross-functional teams in a dynamic environment. The ideal candidate...Regulatory
$159k - $195k
...A leading biotechnology firm in Waltham, MA is seeking an Associate Director of Regulatory Chemistry Manufacturing and Control (CMC). This role involves executing global regulatory strategies and partnering with various teams to support clinical registration and commercial...Regulatory$270k - $330k
...Ipsen Biopharmaceuticals Inc. is looking for a Senior Director of Global Regulatory Affairs specializing in Oncology. This critical role demands extensive regulatory leadership to manage programs, ensuring compliance and strategic alignment with global development objectives...Regulatory- Sanofi is seeking a Global Labeling Strategist to shape the development and implementation of global labeling strategies for products in clinical development. You will collaborate... ...with cross-functional teams, providing regulatory guidance and ensuring alignment between...Regulatory
- ...Global Submission Lead As Global Submission Lead within our R&D team, you will be responsible... ...planning, coordination, and tracking of regulatory priority portfolio and integration... ...companies for implementation of e-submission strategies between two companies. Ensure that...RegulatoryWorldwideFlexible hours
- Global Submission Lead Location: Morristown, NJ / Cambridge, MA. About the role As Global Submission... ..., coordination, and tracking of regulatory Priority portfolio and Integration submission... ...companies for e‑Submission strategies. Coordinate with Regulatory Operations...RegulatoryWorldwide
- ...A leading biopharmaceutical company is seeking an Associate Director for Global Regulatory Affairs in Boston. This role involves leading regulatory strategies for complex projects, ensuring compliance with global regulations, and serving as the primary FDA contact. The...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
$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- ...Allergan is seeking a Senior Director Regulatory Affairs Therapeutic Area Head in Cambridge, MA. This leadership role involves managing global regulatory strategies and supervising a team of global regulatory leads. Applicants should have over 10 years of experience in...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
$246.33k - $304.29k
Akebia Therapeutics is seeking a Senior Director, Regulatory Affairs in Cambridge, MA to lead regulatory strategy and submissions for innovative therapies addressing chronic kidney disease. This role demands extensive regulatory experience, with leadership responsibilities...RegulatoryFlexible hours$130.8k - $209.4k
...Work with exceptional global teams on a broad pipeline... ...and execute stability strategies for assigned... ...alignment with program goals, regulatory expectations, and... ...sections for regulatory submissions, responses, and technical... ...‑related planning. Lead or support investigations...RegulatoryPermanent employmentFull timeRemote work$150k - $200k
Medical Writing Lead, Global Clinical Operations, Orion Pharma Cambridge... ...and play a pivotal role in shaping the future of cancer care.... ...development and global regulatory submissions, ensuring quality and compliance... ..., ensuring document strategy aligns with clinical, regulatory...RegulatoryWorldwide$196.7k - $353.4k
...Moderna is seeking an individual to lead development and execution of global regulatory strategy for programs in its oncology portfolio. This leader will shape regulatory pathways for novel,... ...commercialization Drive regulatory submissions (INDs, CTAs, BLAs/MAAs) with...RegulatoryPermanent employment$249.97k - $388.13k
...The Executive Director, Global Value Evidence Lead, is a strategic leader... ...global value evidence strategy across the company's portfolio... ...stakeholders to shape the value narrative and... ...initiatives to support regulatory, HTA, and payer submissions, and demonstrate the differentiated...RegulatoryTemporary workLocal areaFlexible hours$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- ...Scorpion Therapeutics in Cambridge, Massachusetts is seeking a leader in Global Regulatory Affairs CMC to oversee regulatory strategy and submissions for small molecules and biologics. The ideal candidate should have over 20 years of experience in the industry and a strong...Regulatory
- ...Therapeutics, Inc. seeks an Associate Director for Global Regulatory Affairs Marketed Products in Boston, MA. You will lead global regulatory strategies, advise teams on compliance, and ensure timely project submissions to the FDA. The ideal candidate has extensive...Regulatory
- ...Digital Health is seeking a Senior Regulatory Affairs Specialist in Waltham... .... In this role, you will lead the regulatory efforts for... ...Medical Device (SaMD) across global markets, guiding product teams... ...affairs, especially with FDA submissions. The position offers a competitive...Regulatory
$172k - $236.5k
...their core business strategies, and has been... ...business, focused on shaping and advancing a differentiated... ...value creation Lead portfolio reviews,... ...Development, Regulatory, CMC, Finance,... ...with the Head of Global Initiatives and... ...than candidates. The submission of unsolicited...Regulatory- 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
$137k - $215.27k
...looking for a professional in Boston, MA, to contribute to Global Regulatory Affairs CMC. The role requires 6+ years of regulatory... .... Responsibilities include executing regulatory strategies and managing submissions. The position offers a hybrid work model, with a salary...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
$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$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- ...impact on patients worldwide. Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part of the global... ...Regulatory Lead Oncology you will set global regulatory strategy and lead major submissions for high‑impact oncology programs. How you will...RegulatoryLocal areaWorldwide
- ...experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our... ...and executing regulatory strategies that support global product development... ...expectations. Lead the preparation, submission, and maintenance of regulatory...Regulatory
$174.5k - $274.23k
...Description Objective / Purpose: Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives... ...for the solutions. Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees...RegulatoryMinimum wageFull timeTemporary workLocal areaRemote work
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