Regulatory CMC Manager — Global Strategy & Lifecycle (Remote)
Stoke Therapeutics
- Remote job
Stoke Therapeutics is seeking a Regulatory CMC Manager to drive global regulatory CMC strategies across multiple programs. You will collaborate with cross-functional teams including Regulatory Affairs and Technical Operations to navigate FDA/EMA requirements. The role requires a strong background in Module 3, experience with post-approval CMC activities, and a track record of delivering regulatory milestones in a complex, matrix environment. #J-18808-Ljbffr Stoke Therapeutics
$177k - $278.08k
...Manufacturing & Controls (CMC) and Devices... ...execution of regulatory CMC... ...post-approval strategies for assigned products... ...commercial lifecycle. Demonstrate... ..., line management, and key stakeholders... ...with global regulatory requirements... ...'s Hybrid and Remote Work policy....Remote workMinimum wageLocal areaWorldwide- ...in Indianapolis, Indiana, is seeking a regulatory CMC leader to drive strategic, tactical, and... ...guide development teams, craft regulatory strategies, and provide timely regulatory advice to support global submissions and lifecycle planning. The role emphasizes deep...Remote work
- ...Pharmaceuticals, Inc. seeks an Associate Director, CMC Regulatory Affairs to lead global regulatory strategies for CMC across the product pipeline. You will... ...with FDA/EMA guidance, eCTD submissions, and lifecycle management, driving high-quality regulatory outcomes and timely...Remote workWorldwide
- ...seeking a Director, GRA-CMCD Lifecycle Innovation to provide... ..., and operational regulatory leadership for post-approval CMC activities across Lilly'... ...This role drives lifecycle strategies, data package quality, and... ...timely submissions with global teams across sites and...Suggested
€69.75k - €116.25k per year
...the role Responsible for the CMC regulatory activities in the... ...development and/or early commercial lifecycle management of GSK products. About the... ...responsibilities Be responsible for the global CMC regulatory activities... ...Be responsible for CMC strategy development, with...SuggestedWorldwide$148.5k - $257.4k
...Eli Lilly and Company is seeking a Regulatory CMC Expert in Indianapolis, IN, with the possibility of remote work. This role demands deep expertise in small molecule CMC drug development and significant regulatory experience. Candidates should possess a B.S. in a relevant...Remote workWorldwide- ...Biopharmaceuticals seeks a Director of Global Regulatory Affairs to drive regulatory strategy for development programs, coordinating with clinical, CMC, safety, statistics, and... ...interactions, guiding programs through lifecycle management. The role requires extensive experience...Remote work
- ...for the better. Chiesi Global Rare DiseasesChiesi Global... ...doCurrently seeking a Regulatory Affairs (RA) Manager with strong CMC pre and post approval experience... ...agree on the regulatory strategy for the GRD products... ...working arrangements, remote work options, and tax...Remote workHourly payWork at officeLocal areaRelocation packageFlexible hours
- ...Job Title: Global Regulatory CMC Manager Location: Giralda Farms, NJ , 07940 Duration: 6 Months Hybrid... ...activities through all stages of a product's lifecycle. Members of the organization develop global regulatory CMC strategies and partner with key stakeholders to...Full time
$116k - $151k
...RemoteBe a part of a global team that is... ...Position Summary:The Manager, Regulatory Affairs provides... ...regulatory strategies from development... ...registration and lifecycle management activities... ...Clinical, Nonclinical, CMC, Regulatory... ...expected to be 100% remote.Total Rewards...Remote workFull timeContract workTemporary work- ...NewAmsterdam Pharma is seeking a Director of Global Regulatory Affairs for a remote role in the USA. You will lead regulatory strategy, submissions, and lifecycle management across clinical programs, coordinating with internal teams and external vendors to ensure timely...Remote work
- ...candidate, we can consider remote East Coast) or Copenhagen,... ...Denmark Reporting to : VP, Regulatory Affairs & Quality About... ..., you'll shape and deliver global regulatory strategy for Hemab's development... ...Translate scientific, clinical and CMC data into clear regulatory...Remote work
- ...Kardigan is seeking a Senior Director, CMC Regulatory to lead CMC regulatory strategies and drive global submissions for late-stage assets. The role reports to Head... ...days per week). The successful candidate will manage health authority interactions, ensure compliance...
- ...Ionis Pharmaceuticals, Inc. in Carlsbad, CA, is seeking an Associate Director of CMC Regulatory Affairs to establish and execute global CMC regulatory strategies for commercial compounds. The role collaborates with cross-functional teams, partners, and vendors to deliver...Remote work
- ...Director (Principal Scientist) Global Regulatory Liaison to lead the... ...execution of worldwide regulatory strategies for Immunology programs. As... ...approvals. You will independently manage complex programs, partner... ...regulatory teams through lifecycle submissions and strategic regulatory...Remote jobWorldwide
- ...based/hybrid position. The Manager, Regulatory Affairs CMC is located in El Segundo,... ...with two days of remote working and three days working... ...manufacturing, testing, control strategy, and lifecycle management.Contribute to... ...ensuring alignment with global regulatory requirements...Remote workFull timeContract workFor contractorsWork at officeLocal areaRelocationFlexible hours
$222k - $303k
...joins in. As a global biopharmaceutical... ...Senior Director, Regulatory Affairs CMC - Gene Therapy... ...regulatory CMC strategy plan to facilitate... ...and life cycle management.What You'll Do:... ...development and lifecycle management are communicated... ...This is a fully remote role. It can be...Remote workFull timeLocal areaFlexible hours- Taiho Oncology is seeking a Director for Regulatory CMC to drive global CMC strategy and regulatory submissions for developmental and post‑approval programs across US, EU, and beyond. You will coordinate with internal teams, Japan collaborators, and external consultants...
- Taiho Oncology, Inc. seeks a senior Director to lead global regulatory CMC activities, coordinating strategy, submissions, and approvals across US, EU, and... ...expertise, you will influence regulatory strategies, manage interactions with authorities, and drive submission...
$143.23k - $185.35k
...approach with two days of remote working and three days working... ...ResponsibilitiesRegulatory Strategy and Program LeadershipLead or support integrated global CMC regulatory strategies for both T-cell... ....Guide development and lifecycle management of the T-cell control strategy...Remote workFull timeFor contractorsWork at officeLocal areaRelocationFlexible hours$143.23k - $185.35k
...Job DescriptionThe Senior Manager, Regulatory Affairs CMC supports and drives... ...development and execution of global regulatory strategies, supports end-to-end... ...throughout the product lifecycle. This includes support for... ...approach with two days of remote working and three days...Remote workFull timeFor contractorsWork at officeLocal areaRelocationFlexible hoursShift work- ...Scorpion Therapeutics seeks a Senior Manager, CMC Regulatory Affairs to lead regulatory strategy for biologic drug development and lifecycle management. You will drive global CMC submissions and health... ...rare indications. Based remotely with up to 10% travel, you will...Remote work
$133.2k - $172.37k
## Manager, Regulatory Affairs CMCApply: Onsite - Hybrid Eligible... ...The Manager, Global Regulatory CMC will support Kite’s... ...regulatory submissions, lifecycle management, and... ...with global regulatory strategy and business objectives... ...with two days of remote working and three days...Remote workFull timeWork at officeRelocationFlexible hours- The Senior Manager Global Regulatory Affairs CMC - Biological & Non-Biol. Products is responsible for:Partnering... ...stakeholders to address regulatory strategy challenges and deliver innovative,... ...the development, registration, and lifecycle management of CSL’s biological &...Full timeLocal areaFlexible hours
- ...Participate in the development of the CMC regulatory strategy for small molecules These submissions... ...minimal supervision. Responsible for the global regulatory evaluation of CMC change... ...with supervision. Responsible for the management of CMC activities related to developmental...
$180k - $230k
...Position: Director, Global Regulatory Affairs... ...Location: U.S (Remote) with up to 20% domestic... ...executing global regulatory strategies for assigned development... ...through registration and lifecycle management. The Director,... ..., Nonclinical, CMC, Safety, Biostatistics...Remote workFull timeFor contractorsWork from homeOverseas- ...: North Carolina/Remote If you are interested... .../Sr. Director, Regulatory CMC reports to the... ...responsible for managing the Company’s... ...compliance with global (both U.S. and ex... ...global CMC regulatory strategies, providing... ...aspects of product lifecycle management, including...Remote workFull timeContract workVisa sponsorshipWork visa
$235k - $280k
...: Senior Director, Global Regulatory Affairs Reports to... ...NJ/MA candidates & Remote for out-of-state... ...implementing regulatory strategies for assigned... ...across indications and managing their global lifecycle. The role will play... ...pharmacology, and CMC, ensuring integrated...Remote workMonday to Friday$207k - $253k
...The Director of Regulatory Affairs, Chemistry... ...Manufacturing Controls (CMC) provides... ...functional ownership for global CMC regulatory... ...readiness, and lifecycle management. This role... ...directs CMC regulatory strategy for assigned... ...This is a Hybrid or Remote role that requires...Remote workWork at officeRelocationWeekend work$138.75k - $231.25k
...Global Regulatory Affairs Manager, Oncology We create a place where people can grow,... ...the optimal balance between remote and in-office work. Discover... ...and regional regulatory strategies for oncology assets, ensuring... ...throughout the product lifecycle Drive process improvement,...Remote workWork at officeLocal area
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