Global Regulatory Strategy Lead - FDA Submissions
$153.6k - $241.34kTakeda Pharmaceuticals
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, MA, the position is hybrid and provides a competitive salary range of $153,600 to $241,340. Ideal candidates will demonstrate strong communication skills and a solid understanding of drug development processes. #J-18808-Ljbffr
$196.8k - $295.2k
...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...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- ...Global Submission Lead As Global Submission Lead within our R&D team, you... ...coordination, and tracking of regulatory priority portfolio and... ...implementation of e-submission strategies between two companies.... ...regulations and guidelines, i.e. FDA and EU regulations, and ICH...RegulatoryWorldwideFlexible hours
- Global Submission Lead Location: Morristown, NJ / Cambridge, MA. About the role... ..., and tracking of regulatory Priority portfolio and Integration... ...companies for e‑Submission strategies. Coordinate with Regulatory... ...dossiers. Understanding of FDA, EU regulations, ICH guidelines...RegulatoryWorldwide
- ...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
- ...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... ...and serving as the primary FDA contact. The ideal...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
- ...biopharmaceutical company in Boston is seeking a Regulatory Affairs Specialist to coordinate the preparation of regulatory submission packages. The ideal candidate will have at... ...include managing submissions to the FDA, providing regulatory support to teams, and ensuring...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- ...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... ...prepare regulatory submissions, interact with health authorities like the FDA, and ensure compliance... ...for supporting ongoing global clinical studies. #J-1...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... ...leadership responsibilities in guiding key FDA interactions and overseeing submissions. The position...RegulatoryFlexible hours- 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
$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$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
- ...Health is seeking a Senior Regulatory Affairs Specialist in Waltham... ...Massachusetts. In this role, you will lead the regulatory efforts for... ...Device (SaMD) across global markets, guiding product... ...regulatory affairs, especially with FDA submissions. The position offers a...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- ...Inc is seeking a Director of Regulatory Affairs based in Boston.... ...developing and executing regulatory strategies to support global product development,... ...ability to manage regulatory submissions and work with health authorities such as the FDA and EMA. #J-18808-Ljbffr...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- ...worldwide. Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part of... ...you will set global regulatory strategy and lead major submissions for high‑impact oncology programs.... ...as a member of a GRT. Primary FDA contact for projects of responsibility...RegulatoryLocal areaWorldwide
- ...and strategic Director of Regulatory Affairs to lead and support global regulatory efforts... ...and executing regulatory strategies that support global product... ...Lead the preparation, submission, and maintenance of regulatory... ...authorities, including FDA, EMA, and other major...Regulatory
$174.5k - $274.23k
...Description Objective / Purpose: Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives... ...success for the solutions. Accountable for all US FDA submissions and approvals of project(s) of responsibility or...RegulatoryMinimum wageFull timeTemporary workLocal areaRemote work- ...Takeda seeks an Associate Director, Global Labeling Lead to manage the development of labeling content for various products. This role demands... ...management skills and extensive knowledge of US and EU regulatory requirements. Candidates should have over 8 years in the pharmaceutical...RegulatoryFull timeRemote work
- ...Takeda Pharmaceuticals International GmbH is seeking a Head of Regulatory Legal in Cambridge, Massachusetts. This role involves developing and leading the legal strategy for Global Quality, R&D, and Regulatory Affairs. The candidate will provide high-level legal counsel...Regulatory
- ...Therapeutics, Inc. is seeking a seasoned regulatory leader to develop and execute global regulatory strategy for its oncology portfolio. The role requires... .... Key responsibilities include leading regulatory submissions and health authority interactions, anticipating...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
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Global Regulatory Strategy Lead - FDA Submissions. Be the first to apply!

