Global Regulatory CMC Lead: Submissions & Strategy (Hybrid)
Takeda Pharmaceuticals
Takeda in Boston is seeking an experienced professional to lead Regulatory CMC strategies and manage regulatory submissions. The candidate should have over 6 years of experience in pharmaceutical regulatory affairs and a strong foundation in CMC regulations. This role plays a critical part in ensuring product success and compliance with regulatory requirements. This position offers a hybrid working arrangement and competitive benefits including salary and health insurance options. #J-18808-Ljbffr Takeda
$177k - $278.08k
JobRx, Inc. is seeking a Regulatory Affairs professional in Boston... ..., MA to manage regulatory CMC strategy for pharmaceutical... ...experience with a strong focus on leading major submissions and ensuring regulatory... ...compliance. This position offers a hybrid work model and a...Regulatory- Takeda in Boston is looking for a GRA CMC Product Lead to oversee regulatory CMC strategies and lead submissions for investigational, registration, and post-approval processes... ...of CMC regulations. This position offers a hybrid work model along with competitive compensation...Regulatory
- A leading biopharmaceutical company is seeking a Director of Regulatory CMC in Boston, MA. This key role involves managing post-approval... ..., ensuring compliance with global regulations, and leading... ...while driving innovative regulatory strategies. #J-18808-Ljbffr TakedaRegulatory
$137k - $215.27k
...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 range of $137,000...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... ...in Boston, MA, the position is hybrid and provides a competitive salary range...Regulatory$113.85k - $189.75k
...Position Summary You will lead Chemistry, Manufacturing, and Controls (CMC) regulatory strategy and execution for... ...FDA expectations and global standards. Prepare... ...focus on IND and BLA submissions to the FDA. Experience... ...model This role is hybrid. You will be expected...RegulatoryFull timeLocal area- 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
$238k - $374k
...Executive Director of Global Regulatory Affairs in Boston, MA. This role entails leading a team to oversee the regulatory strategy for medical devices and... ...track record in managing submissions and aligning cross-... ...The position offers a hybrid work model, competitive...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
- 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
- Moderna Therapeutics in Norwood, MA is seeking a Regulatory CMC Lead to manage a team of CMC experts. This role involves overseeing regulatory strategies for a portfolio of products, ensuring compliance with health authority guidelines, and leading interactions with regulators...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$212k - $333.19k
...Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug-... ...product regulatory strategies particularly pertaining... ...implementation. Globally influences and... ...global regulatory submissions (e.g., Core Dossiers... ...currently classified as hybrid following Takeda's...RegulatoryMinimum wageTemporary workLocal areaRemote workWorldwideNight shift- 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
$122.25k - $176.58k
Job title: Global Submission Lead Location: Morristown, NJ / Cambridge, MA. About the job As Global... ..., coordination, and tracking of regulatory Priority portfolio and Integration submission... ...for implementation of e‑Submission strategies between two companies. Ensure that...RegulatoryWorldwideFlexible hours$154.4k - $242.55k
...for the world. As a global, values‑based... ...Global Risk Financing Strategy and ensuring... ...group strategy. Lead specific Global Insurance... ...of underwriting submissions and support any market... ...challenges and/or regulatory issues; recommend... ..., MA. This is a hybrid role with onsite...RegulatoryMinimum wageFull timeContract workTemporary workWork at officeLocal areaImmediate start$177k - $278.08k
...This role is within the Global Regulatory Affairs (GRA)... ...Manufacturing & Controls (CMC) and Devices organization... ...the regulatory CMC strategy and leads the execution of... ...global registrational submissions of complex drug product... ...currently classified as hybrid following Takeda's...RegulatoryMinimum wageTemporary workLocal areaImmediate startRemote workWorldwide$177k - $278.08k
...This role is within the Global Regulatory Affairs (GRA)... ...Manufacturing & Controls (CMC) and Devices organization... ...the regulatory CMC strategy and leads the execution of... ...global registrational submissions of complex drug product... ...currently classified as "hybrid" following Takeda's...RegulatoryMinimum wageFull timeTemporary workLocal areaRemote workWorldwide$137k - $215.27k
...role is within the Global Regulatory Affairs (GRA)... ...Manufacturing & Controls (CMC) and Devices... ...supervision, leads the execution of... ...or post-approval strategies for assigned products... ...and accurate submissions. Develops constructive... ...classified as hybrid following Takeda'...RegulatoryMinimum wageFull timeTemporary workLocal areaRemote workWorldwide- ...biopharmaceutical company in Boston is seeking a Regulatory Affairs Specialist to coordinate the preparation of regulatory submission packages. The ideal candidate will have at... ...drugs, and a strong understanding of CMC requirements. Key responsibilities include managing...Regulatory
- ...Rosa Therapeutics is seeking a Regulatory Operations Manager in Boston,... ...with proficiency in eCTD submissions and vendor oversight. The candidate... ..., maintain compliance with global standards, and prepare... ...position offers an opportunity to lead cross-functional teams and contribute...Regulatory
$238k - $374k
JobRx, Inc. is seeking an Executive Director for Global Regulatory Affairs CMC Early Development based in Boston. The ideal candidate will provide... ...strategic leadership, overseeing global CMC regulatory strategies for small molecules and biologics through Phase 2, and working...Regulatory$238k - $374k
...Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device... ...robust regulatory strategies for medical devices... ...you will contribute: Leads and develops a team... ...strategy and major submissions for an assigned portfolio... ...classified as hybrid following Takeda's Hybrid...RegulatoryMinimum wageTemporary workWork at officeLocal areaRemote workWorldwide- ...seeking a seasoned professional for a role in Global Regulatory Affairs, focusing on Chemistry Manufacturing & Controls. The successful candidate will lead the development of regulatory CMC strategies and manage submissions critical to product lifecycle. Applicants must...Regulatory
$125k - $258k
A leading compliance firm in Boston is seeking a Head of Global Sanctions to oversee the enterprise-wide sanctions program. This role requires a senior executive... ...robust compliance while navigating complex regulatory landscapes. The position offers a competitive salary...Regulatory- ...and strategic Director of Regulatory Affairs to lead and support global regulatory efforts... ...and executing regulatory strategies that support global product... ...background is preferred. CMC experience is a plus.... .... Lead the preparation, submission, and maintenance of regulatory...Regulatory
- ...Alfasigma is seeking a Manager, Regulatory Lead to support regulatory strategy development and IND submissions in a fast-paced environment based in Boston. This role involves collaboration and project management across various functions. Ideal candidates will have...RegulatoryRemote work
- ...Cambridge, MA is seeking an Associate Director, Regulatory Affairs CMC to lead the development and execution of global regulatory strategies for innovative therapeutics, particularly... ...leadership. The position allows for hybrid work arrangements, reflective of Alnylam's...Regulatory
$177k - $278.08k
...Purpose: Defines, develops and leads global strategies to maximize global regulatory success towards achievement of... .... Accountable for all US FDA submissions and approvals of project(s) of responsibility... ...is currently classified as “hybrid” in accordance with Takeda’s...RegulatoryMinimum wageFull timeTemporary workLocal areaRemote work- 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
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