Global CMC Regulatory Lead for Early Development
Scorpion Therapeutics
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 understanding of regulatory requirements. This position demands a cooperative team leader who can work with regional teams and must possess an advanced degree in a relevant scientific discipline. Strong negotiation and communication skills are essential, as well as a strategic mindset to navigate complex challenges. #J-18808-Ljbffr
$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- Initial Therapeutics, Inc. is seeking an Executive Director in Global Regulatory Affairs CMC Early Development to provide strategic leadership and development for regulatory strategies of small molecule and biologic products. You will oversee a team and align cross-functional...Regulatory
- ...therapies to patients worldwide. As Executive Director, Global Regulatory Affairs CMC Early Development you will provide strategic leadership and development... ...Japan, China). How you will contribute: Leads and develops a team of regulatory leaders and subject...RegulatoryRemote workWorldwide
- ...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... ...regulatory CMC relevant to drug development. Strong leadership and communication...Regulatory
- Job title: Global Regulatory Strategist Location: Morristown, NJ/... ...oncology therapeutic area, leading regulatory efforts in the development stage of drug products.... ...nonclinical, clinical, CMC, commercial, and other... ...company that engages patients early in drug development and...RegulatoryLocal area
$137k - $215.27k
...Initial Therapeutics, Inc. is looking for a professional in Boston, MA, to contribute to Global Regulatory Affairs CMC. The role requires 6+ years of regulatory CMC or Device experience and a BS/BA degree in a scientific discipline. Responsibilities include executing regulatory...Regulatory- ...A leading BioPharmaceutical company seeks a Senior Director, Global Regulatory Strategy, to lead regulatory efforts for early-stage products and ensure alignment with health authority expectations. The role demands extensive regulatory experience in the pharmaceutical...Regulatory
$148.5k - $214.5k
...Job title : CMC dossier leader ~ Location... ...discovery and development to find answers... ...within Sanofi R&D Global CMC Development organization... ...in leading the preparation of CMC dossiers for regulatory submissions to enable... ...engages patients early in drug development...Regulatory$177k - $278.08k
...This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and... ...the regulatory CMC strategy and leads the execution of regulatory CMC... ...to Regulatory, Pharmaceutical Development, and Commercial project teams...RegulatoryMinimum wageTemporary workLocal areaImmediate startRemote workWorldwide$177k - $278.08k
...worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and... ...regulatory CMC strategy and leads the execution of regulatory... ...to Regulatory, Pharmaceutical Development, and Commercial project teams...RegulatoryMinimum wageFull timeTemporary workLocal areaRemote workWorldwide$137k - $215.27k
...worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and... ...: With some supervision, leads the execution of regulatory CMC... ...at Regulatory, Pharmaceutical Development, and Commercial project teams...RegulatoryMinimum wageFull timeTemporary workLocal areaRemote workWorldwide$212k - $333.19k
...patients worldwide. As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug-Device Combinations... ...you will provide leadership for the development and implementation of innovative... ...and proactive implementation. Globally influences and serves as a key opinion...RegulatoryMinimum wageFull timeTemporary workLocal areaRemote workWorldwideNight shift$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... ...registration and commercial development. Candidates should...Regulatory$238k - $374k
...patients worldwide. As Executive Director, Global Regulatory Affairs CMC Devices and Drug‑Device Combination... ...provide strategic leadership and development to global regulatory subject matter... ...Japan, China). How you will contribute Leads and develops a team of regulatory...RegulatoryTemporary workWork at officeLocal areaRemote workWorldwide- ...impact on patients worldwide. Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part of the global regulatory team... ...activities of one or multiple complex projects in development and/or supports regulatory activities for assigned projects...RegulatoryLocal areaWorldwide
$177k - $278.08k
...Objective / Purpose: Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for... ...tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring...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 strong project... ...skills and extensive knowledge of US and EU regulatory requirements. Candidates should have over 8 years in...RegulatoryFull timeRemote work
$148.5k - $214.5k
Sanofi is seeking a CMC dossier leader to manage the preparation and development processes within the CMC Dossier Sciences team. This role focuses on leading cross-functional teams and ensuring timely regulatory submissions while leveraging digital tools and AI solutions...Regulatory$208.2k - $327.14k
...on patients worldwide. Join Takeda as a Senior Director, Global Regulatory Lead – Oncology, where you will be part of the global regulatory... ...ensure innovative and robust strategies are in place from development through registration and launch readiness for high-impact...RegulatoryMinimum wageFull timeTemporary workLocal areaWorldwide- Sanofi is seeking a Global Labeling Strategist to shape the development and implementation of global labeling strategies for products in clinical development... ...collaborate with cross-functional teams, providing regulatory guidance and ensuring alignment between evidence...Regulatory
- ...Medical Affairs Lead, Global Rare Diseases - Contractor Department: GRD Global Medical Affairs... ...February 2020 and focused on research, development and commercialization of treatments and... ...-affiliate teams. Familiarity with regulatory and compliance requirements for training...RegulatoryContract workTemporary workFor contractorsLocal area
- ...Senior Vice President Global Regulatory Affairs. Their approach... ...executive to lead our global regulatory... ...transition toward late‑stage development. The SVP, Global Regulatory... ...strategy spanning early development through registration... ...deeply with Clinical, CMC, Biomarker, Program...Regulatory
$170.9k - $231.3k
...Associate Director, Regulatory Affairs, CMC The Associate Director... ...Affairs CMC Development is responsible for developing... ...and implementing global CMC regulatory strategies... ...: Lead the development and execution... ...complex modalities across early- and late-stage...RegulatoryFull timeTemporary workWork at officeLocal area- ...clinical care and research, drug development, and cancer biology, and... ...the selected candidate will lead a team of MS&T professionals... ...operational leadership for the CMC execution and lifecycle management... ..., Quality Assurance, Regulatory and the Program Team. You will...RegulatoryWork at office2 days per week3 days per week
$285k - $350k
...asset-centric model can lead to improved success... ...The Executive Director, Regulatory CMC will provide strategic leadership for global CMC regulatory activities... ...across all stages of drug development and life cycle... ...Demonstrated experience across early-stage, late-stage...RegulatoryFull time$154.4k - $242.55k
...worldwide. Join Takeda as Associate Director, Global Labeling Lead where you will be responsible for the development and implementation of labeling content and strategy... ...labeling content and processes conform to regulatory requirements. Management of Local Exceptions and...RegulatoryMinimum wageFull timeTemporary workLocal areaRemote workWorldwide- ...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. This role requires a strong background in biopharmaceuticals with 10+ years in the industry...Regulatory
$169.4k - $266.2k
...deliver your best. As part of the Global Medical Affairs Oncology team... ...Communications Group Lead, Solid Tumors. As a subject... ...publications best practices and the development of scientific communication... ...‑analyses. Compliance and Regulatory: Excellent understanding of regulatory...RegulatoryMinimum wageFull timeFor contractorsWork experience placementFreelanceLocal areaRemote work- ...Therapeutics, Inc. is 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...Regulatory
- ...Takeda is seeking a Director Regulatory Site CMC in Boston, MA, to lead regulatory change management activities and ensure compliance with global HA requirements. The ideal candidate has over 10 years of biopharmaceutical/device industry experience and a strong understanding...Regulatory
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