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- ...CRISPR Therapeutics, based in Boston, is seeking an Associate Director for Regulatory Affairs CMC to oversee regulatory strategies for innovative gene therapies. This leadership role requires extensive experience in CMC regulatory requirements for biologics and gene therapies...RegulatoryRemote workFlexible hours
- Recursion, a clinical‑stage TechBio company, seeks a Director CMC Regulatory Affairs to lead regulatory strategy for small molecule programs across US, EU and ROW. You’ll coordinate internal and external contributors and drive region‑specific CMC documents (Module 2/3,...RegulatoryRemote job
$285k - $320k
BridgeBio is hiring for a CMC Regulatory Lead in San Francisco, responsible for leading regulatory strategies for drug approvals and submissions. Candidates should have extensive experience in Regulatory Affairs CMC within the biotech or pharmaceutical industry and be...RegulatoryRemote job- A leading biopharmaceutical company is seeking an Associate Director/Director of Regulatory CMC to manage CMC functions and ensure compliance with global regulations. The ideal candidate has 5-10 years of experience in Regulatory CMC, a strong technical background in relatorette...RegulatoryRemote job
- NewAmsterdam Pharma Corporation is seeking a Senior Manager CMC Regulatory Affairs to oversee global CMC regulatory strategies for clinical development programs and marketing applications. The role is remote and emphasizes collaboration with various departments to ensure...RegulatoryRemote job
- Job DescriptionGeneral Summary:The Associate Director, CMC Quality Compliance and Inspection Readiness, is responsible for inspection... ...and governance forumsKnowledge and Skills:Knowledge of regulatory requirements and inspection expectations globallyExperience in...RegulatoryFull timeSummer workRemote workFlexible hours2 days per week
- Erasca is seeking a Sr Manager/Assoc Director, CMC Regulatory Affairs to lead regulatory activities for IND/CTA development and ongoing trials. The role involves preparing CMC documents, ensuring regulatory compliance, and coordinating global submissions. The ideal candidate...RegulatoryRemote job
- ...seeking an Associate Director, Technical Operations (Small Molecule CMC) to provide technical oversight for API development and... ...manufacturing at Travere CDMOs. This role collaborates across Quality, Regulatory Affairs, Clinical and Supply Chain to align on risk and...RegulatoryRemote job
- BeOne Medicines Ltd invites applications for a Regulatory Affairs CMC Intern to support global regulatory submissions and knowledge management. The role offers exposure to CMC regulatory activities, data maintenance, and collaboration with QA, Supply Chain, and IT. The...RegulatoryRemote jobInternship
$166.4k - $249.6k
Job 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$190.4k - $285.6k
Job DescriptionGeneral Summary:The Director, Chemistry Manufacturing Controls (CMC) leads a Regulatory CMC team responsible for developing and executing global regulatory strategies across multiple investigational and commercial products in the small molecule portfolio....RegulatoryFull timeSummer workRemote workFlexible hours2 days per week$142.5k - $256.5k
The RoleThe Associate Director, Global Regulatory, CMC will be responsible for coordinating regulatory CMC activities for one or more products, depending on complexity, through all stages of a products lifecycle. The Associate Director will be responsible for developing...RegulatoryPermanent employmentFull timeWork at officeWork from home- Job DescriptionGeneral Summary:The CMC Quality Compliance Director is responsible for inspection readiness and compliance of internal... ...manufacturing/testing sites. Monitor and interpret cGMP regulatory guidelines and trends in the regulatory space and incorporate into...RegulatoryFull timeWork experience placementSummer workRemote workFlexible hours2 days per week
$132k - $172k
...paths as we move toward a common goal of elevating science and service for rare patients.Position Summary:The Senior Manager, CMC Regulatory Affairs is responsible for providing strategic and operational regulatory leadership for Chemistry, Manufacturing, and Controls...RegulatoryFull timeTemporary workRemote work$132k - $172k
...paths as we move toward a common goal of elevating science and service for rare patients.Position Summary:The Senior Manager, CMC Regulatory Affairs is responsible for providing strategic and operational regulatory leadership for Chemistry, Manufacturing, and Controls...RegulatoryFull timeTemporary workRemote workWorldwide- ...seeking an Associate Director, Technical Operations (Small Molecule CMC) to provide technical oversight of API development and manufacturing with Travere CDMOs. This role partners with Quality, Regulatory Affairs, Clinical, and Supply Chain to ensure milestone alignment...RegulatoryRemote job
- ...patient advocacy and care. Discover more here.Who we are looking forThis is what you will doCurrently seeking a Regulatory Affairs (RA) Manager with strong CMC pre and post approval experience to support Chiesi’s Global Rare Diseases (GRD) global portfolio of commercial...RegulatoryHourly payWork at officeLocal areaRemote workRelocation packageFlexible hours
$150k - $195k
...paths as we move toward a common goal of elevating science and service for rare patients.Position Summary:The Associate Director, CMC Regulatory Affairs is responsible for providing strategic and operational regulatory leadership for Chemistry, Manufacturing, and Controls...RegulatoryFull timeTemporary workRemote work$246.98k - $299.29k
...personal lives. Read more: careers.bms.com/working-with-us.The GRS-CMC Director is responsible for overseeing management of multiple... .... Develop and communicate strategic direction based on global regulatory guidelines and experience. Seeks opportunities for external...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$148.5k - $257.4k
...people who are determined to make life better for people around the world.This role provides strategic, tactical and operational regulatory CMC leadership across therapeutic modalities and manufacturing technologies to expedite development of the small molecule portfolio...RegulatoryRemote workRelocation packageFlexible hours- ...seeks an Associate Director of Technical Operations (Small Molecule CMC) to provide technical oversight of API development and manufacturing at Travere CDMOs. You will collaborate with Quality, Regulatory Affairs, Clinical, and Supply Chain to meet program milestones for...RegulatoryRemote job
$177k - $278.08k
...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 follows...RegulatoryMinimum wageTemporary workLocal areaRemote workWorldwide$150k - $195k
...Summary:The Associate Director, Technical Operations (Small Molecule CMC) will provide technical oversight for small molecule API... ...drug products.This individual will partner closely with Quality, Regulatory Affairs, Clinical, and Supply Chain to ensure alignment, risk...RegulatoryFull timeContract workTemporary workRemote work- ...non-commercial programs, ensuring compliance with GMP/GDP standards. The role involves authoring and reviewing IND CMC submissions, managing quality systems, supporting regulatory inspections, and collaborating with internal #J-18808-Ljbffr Amylyx Pharmaceuticals, Inc.RegulatoryRemote job
$238k - $374k
...boundaries of what is possible in order to bring life-changing therapies to patients worldwide.As Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Product, you will provide strategic leadership and development to global regulatory...RegulatoryMinimum wageTemporary workWork at officeLocal areaRemote workWorldwide$144.06k - $205.8k
...making a tangible impact.Purpose and Scope:This position plays a key global leadership role in the Regulatory Affairs department for the Chemistry, Manufacturing and Controls (CMC) aspects of regulatory documents and submissions. Responsible for multiple regulatory...RegulatoryWork at officeLocal areaRemote workWork from homeWorldwide$238k - $374k
...information I submit in my employment application is true to the best of my knowledge.Job DescriptionExecutive Director, Global Regulatory Affairs CMC Early DevelopmentAre you looking for a patient-focused company that will inspire you and support your career? Join us as...RegulatoryMinimum wageTemporary workLocal areaRemote work$224.9k - $404.6k
...position will be based at Norwood MA site and will be responsible for managing a team of CMC experts that prepare and oversee CMC and Quality related agency correspondence and regulatory applications. This position will be required to oversee the product strategy for all...RegulatoryPermanent employmentFull timeWork at officeWork from home$285k - $320k
...experimentation—including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work. What You'll Do Lead CMC regulatory strategy and execution across development and post‑approval programs, ensuring high‑quality submissions aligned with global...RegulatoryWork at officeRemote workFlexible hoursBridgeBio
San Francisco, CA4 hours agonew$167k - $300.7k
...Digital Operations and Strategic Portfolio Management, the Director, CMC Digital Operations and Strategic Portfolio Management will own... ...in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (...RegulatoryPermanent employmentFull timeWork at officeWork from homeShift work
