Global Regulatory CMC Leader for Biologics & ATMPs
Biogen Inc
Biogen in Cambridge, MA is seeking a Head of Regulatory CMC for Biologics & ATMPs. This hybrid role leads a global CMC regulatory strategy, aligning development, manufacturing, and regulatory activities to ensure timely approvals and lifecycle progression. You will guide interactions with Health Authorities, oversee post-approval changes, and collaborate across Technical Operations, Quality, and Supply Chain. A senior leader with depth in regulatory sciences and biologics/ATMPs is required. #J-18808-Ljbffr Biogen
- Biogen seeks a Head of Regulatory CMC - Biologics & Advanced Therapy Medicinal Products to lead the regulatory strategy across biologics and ATMPs. Based in Cambridge, MA, you will align regulatory... ...management. You will manage a global team, influence external Health...Regulatory
$241k - $332k
About This Role:As the Head of Regulatory CMC - Biologics & Advanced Therapy Medicinal Products (ATMP), you will lead a dynamic team... .... Your role encompasses global, regional, and local accountability... ...Who You Are:You are a visionary leader with a deep understanding of...RegulatoryFull timeTemporary workLocal area- Moderna is seeking an Associate Director, Global Regulatory, CMC to coordinate regulatory CMC activities across product lifecycles and develop... .... The role requires 8+ years in pharma/biotech with biologics CMC regulatory experience, strong CTD knowledge, and excellent...Regulatory
- Moderna seeks an Associate Director, Global Regulatory-CMC in Norwood, Massachusetts. This role involves coordinating regulatory CMC activities... ...at least 8 years in the biotech space, particularly in biologics-focused regulatory CMC. The position offers a competitive salary...Regulatory
$166.4k - $249.6k
...DescriptionGeneral Summary:The Chemistry Manufacturing Controls (CMC) Associate Director leads and executes global regulatory CMC strategies across investigational and commercial products focusing on biologics. This role is accountable for authoring, reviewing, and...RegulatoryFull timeSummer workRemote workFlexible hours2 days per week$238k - $374k
...knowledge.Job DescriptionExecutive Director, Global Regulatory Affairs CMC Early DevelopmentAre you looking for... ...submissions for small molecule and biologic products through Phase 2 development.... ...execution.• Serves as an influential leader internally and externally, shaping...RegulatoryMinimum wageTemporary workLocal areaRemote work- 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
$148.5k - $214.5k
...Job title CMC dossier leader Location : Framingham, MA About the job Are you ready to shape the... ...Sciences department within Sanofi R&D Global CMC Development organization has critical... ...the preparation of CMC dossiers for regulatory submissions to enable advancement of...Regulatory$212k - $333.19k
...shine? Join us as a Senior Director, Global Program Leader - Oncology, Solid Tumors in our Cambridge... ...to simultaneously driving regulatory approval as well as launch and global... ...Commercial Subteam, Pharmaceutical Sciences (CMC) Subteam, etc. to the GPT through function...RegulatoryMinimum wageTemporary workWork at officeLocal areaRemote workNight shift- Moderna is seeking an Associate Director, Global Regulatory, CMC to coordinate CMC regulatory activities across product lifecycles and to develop global strategies that align with business priorities. You will guide product teams, prepare CMC and Quality submissions, and...Regulatory
- Moderna is seeking an Associate Director, Global Regulatory-CMC to coordinate regulatory CMC activities across product lifecycles, develop global CMC strategies, and guide product teams in preparing agency correspondence and regulatory applications. The role leads interactions...Regulatory
$142.5k - $256.5k
The RoleThe Associate Director, Global Regulatory, CMC will be responsible for coordinating regulatory CMC activities for one or more products... ...You’ll Need (Basic Qualifications)BS/MS/PhD in Molecular Biology, Pharmaceutics, Chemistry, Chemical Engineering, or closely...RegulatoryPermanent employmentFull timeWork at officeWork from home$177k - $278.08k
...is possible in order to bring life-changing therapies to patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of critical functions as...RegulatoryMinimum wageTemporary workLocal areaRemote workWorldwide$142.5k - $256.5k
Role Overview The Associate Director, Global Regulatory-CMC will coordinate regulatory CMC activities for one or more products throughout their... ...programs. Basic Qualifications BS, MS, or PhD in Molecular Biology, Pharmaceutics, Chemistry, Chemical Engineering, or closely...Regulatory$238k - $374k
...changing therapies to patients worldwide.As Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Product, you will... ...and manufacturing interfaces.Serve as an influential leader internally and externally, shaping regulatory policy and cross...RegulatoryMinimum wageTemporary workWork at officeLocal areaRemote workWorldwide$202.5k - $337.5k
Global CMC Automation and Robotics Leader 2 weeks ago Be among the first 25 applicants This range is provided by Sanofi. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range $202,500.00/yr - $337,500.00/yr...Full timeLocal area$177k - $278.08k
...-class and best-in-class therapies, including ADCs, complex biologics and small molecules. Our goal is to accelerate access to transformative... ...impact on patients worldwide.Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part of the global...RegulatoryMinimum wageTemporary workLocal areaRemote workWorldwide$251.61k - $377.42k
Global Product Leader, Late CVRM - Weight ManagementAre you an inspiring leader with extensive experience in late-stage drug development? Do... ...external information on the product, including publications, regulatory documents, and clinical trial registers.• Manage and...RegulatoryHourly payFull timeTemporary work- Philips is seeking a Head of Regulatory for Ambulatory Monitoring & Diagnostics to lead global regulatory strategy, ensuring compliance across development and commercialization. You will manage a team of Regulatory Affairs professionals and drive risk mitigation, submissions...Regulatory
$196k - $269.5k
...realize our ambitions, the argenx Global Commercial Team is looking... ...with key opinion leaders and other key stakeholdersManage... ...sciences or additional education in biology, chemistry, life sciences preferredPreferred... ...understanding of the legal, regulatory and commercial environment...RegulatoryFull timeTemporary workWork at officeRemote work- Acrivon 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
- Biogen is seeking a Head of Global Product Quality for Biologics to lead a dynamic team responsible for all product quality aspects within Biogen’s... ...position requires extensive GMP/GxP expertise, global regulatory experience, and a proven track record in #J-18808-Ljbffr...Regulatory
$184k - $253k
...This Role As the Head of Global Product Quality for Biologics, you will lead a dynamic team... ...business partners, the CMC Asset Team, and the Quality... ...a modality. Review major regulatory submissions and help set up... ...Are You are an inspiring leader with a passion for quality...RegulatoryTemporary workWork at officeLocal area- ...Director of Epidemiology and Real-World Evidence Sciences to lead the global evidence strategy for Ipsen’s oncology assets across the product lifecycle. You will guide RWE generation and regulatory support, collaborating with Asset Teams, Biostatistics, and external partners...Regulatory
- Sanofi, a leader in biopharma and AI-powered science, seeks a Global Lead for Health Ecosystem & Innovation to build external partnerships with startups, academia... ...medical innovation while navigating a complex regulatory environment and global partners. #J-18808-Ljbffr...Regulatory
- Moderna seeks a Global Medical Director to lead medical affairs strategy across our Oncology portfolio, spanning early development through... ...generation, and cross-functional alignment, interfacing with regulatory, clinical, and commercial functions. The successful candidate...Regulatory
- Sarepta Therapeutics is seeking an Associate Director of Regulatory Labeling and Disclosures to lead global labeling activities for development and marketed products. You will partner with cross-functional teams to ensure compliant labeling, CCDS, and local labeling across...RegulatoryLocal area
- Ipsen seeks a senior leader to guide the Global Asset Team in maximizing asset value from development to commercialization, spanning oncology indications... ...role requires shaping strategy, aligning across clinical, regulatory, commercial, and Medical Affairs, and reporting to...Regulatory
$200k - $300k
A biopharmaceutical company in Cambridge is seeking a Director or Senior Director of Regulatory Strategy. This role involves developing and implementing global regulatory strategies for clinical programs and leading interactions with regulatory authorities. Candidates...Regulatory- ...headquarters. You’ll own end-to-end governance for global product launches and major lifecycle events,... ...activities with robust supply, quality, regulatory, and flow-of-goods strategies. You will partner with Asset Leaders and senior stakeholders to align commercial ambition...Regulatory
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