Regulatory CMC Manager, Cell & Gene Therapy
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Legend Biotech in Somerset, NJ, is seeking a Manager, Regulatory CMC to lead the development and execution of global CMC regulatory strategies for pipeline cell and gene therapy programs, including CAR-T and viral vectors. The role involves authoring and reviewing regulatory documents, coordinating with Process Development, Manufacturing, Analytical Development, and Quality teams, and ensuring compliance with FDA, EMA and ICH guidelines. #J-18808-Ljbffr Socket.dev
- Legend Biotech US in Somerset, NJ is seeking a Manager, Regulatory CMC to lead global CMC regulatory strategies for pipeline cell and gene therapy programs, including CAR-T products, with a focus on dossier authoring and cross‑functional collaboration. You will partner...Suggested
- Legend Biotech US in Somerset, New Jersey, is seeking a Manager, Regulatory Project Management to support planning and execution of Cell & Gene Therapy programs. You will coordinate activities across Research, CMC, Quality, Regulatory Affairs, Clinical Operations and external...Suggested
- Legend Biotech is seeking a Manager, Regulatory Project Management in Somerset, NJ to support planning and execution of Cell & Gene Therapy programs. You will coordinate activities, monitor timelines, and provide administrative support to ensure milestones are met, working...Suggested
- Legend Biotech USA Inc. is hiring a Manager, Regulatory Project Management in Somerset, NJ. You will coordinate cross‑functional teams... ...project timelines, and support IND submissions to advance cell and gene therapy programs. The role requires 1-3 years in project...SuggestedWork at office
$127.31k - $167.1k
...are advancing the next generation of cell therapy through a portfolio of innovative technologies... ...myeloma. Legend Biotech is seeking a Manager, Regulatory CMC as part of the Regulatory Affairs team... ...supporting biologics, cell and gene therapy products, or extensive experience...SuggestedPermanent employmentFull timeTemporary workFor contractorsLocal areaWorldwideFlexible hours$204k - $244k
...stage biotechnology company advancing gene therapies with curative potential for patients... ...Rocket Pharma is seeking a Director, Regulatory Affairs – CMC (Chemistry, Manufacturing, and Controls... ...Affairs, they will proactively manage multiple Regulatory CMC projects by coordinating...Temporary workLocal areaShift work$150k - $195k
Department: 107000 Regulatory Location: San Diego, USA-... ...deliver life-changing therapies to people living with... ...The Associate Director, CMC Regulatory Affairs is... ...applications, and lifecycle management activities for... ...regulatory considerations for cell line and process...Temporary workRemote work- Legend Biotech USA is seeking a Director of Regulatory Affairs in Somerset, NJ. You will independently develop and execute global regulatory strategies, for oncology/cell therapy programs, and lead IND/CTA/BLA submissions with cross-functional teams. You will interact...
$132k - $172k
Department: 107000 Regulatory Location: San Diego, USA- Remote Be a part of a global team... ...identify, develop and deliver life-changing therapies to people living with rare disease. We... ...patients. Position Summary The Senior Manager, CMC Regulatory Affairs is responsible for...Temporary workRemote work- ...Position:Director/Senior Director Regulatory AffairsDepartment:Regulatory AffairsLine Manager / Supervisor Job Title /... ...liaison to regulatory authorities for gene therapy productsMajor Activities and ResponsibilitiesDevelop... ...in alignment with nonclinical, CMC and clinical development plans...Remote work
$193.63k - $254.14k
...advancing the next generation of cell therapy through a portfolio of... ...Biotech is seeking a Director, Regulatory Affairs as part of the... ...regular and timely updates to management on the status of all pending... ...representatives. Experience in cell and gene therapy is a plus....Permanent employmentFull timeTemporary workFor contractorsLocal areaWorldwideFlexible hours- Summit Strategic Search partnering with a global biopharma client seeks a Director of Regulatory Affairs to lead global regulatory strategy from early development through approval. The role reports to senior leadership and influences cross-functional teams, including direct...
$190k - $250k
Own the global regulatory strategy that carries breakthrough cell therapies from early development through health-authority approval... .... Submissions & Lifecycle Management Lead the team effort to prepare... ...with biologics and cell and gene therapies. Experience across multiple...Permanent employmentFull time- Legend Biotech seeks a Director of Regulatory Affairs in Somerset, NJ to independently develop global regulatory strategies and coordinate execution across cross‑functional teams. You will oversee regulatory filings for the Legend pipeline, interact with authorities, and...
- ...Innovative company designing & developing gene therapeutic products Industry... ...Pharmaceuticals Genetics Specialties gene therapy adeno-associated virus... ...will be responsible for the operational management of GxP Compliance Audit and Supplier Quality...For contractors
$200k - $250k
Senior Director, Regulatory Strategy Consulting 4 days ago - Be among... ...Development Provide line management and performance management... ..., and/or regulatory CMC. Experience across multiple... ...mABs, ADCs), small molecules, cell and gene therapy, oligonucleotides, peptides...Full timeRemote work- ...Description NewAmsterdam Pharma (NAP) is seeking a Senior Manager CMC Regulatory Affairs who will support the development and execution of global... ...of lipid‑lowering treatment. By advancing innovative therapies for cardiovascular disease (CVD) and other lipid‑related conditions...Local areaRemote work
- Recursion, a clinical‑stage TechBio company, seeks a Director CMC Regulatory Affairs to lead regulatory strategy for small molecule... ...collaboration with Regulatory Affairs leadership to advance clinical programs and lifecycle management. #J-18808-Ljbffr Segment (Twilio)Remote job
$207.5k - $255.2k
...The Impact You’ll Make Lead development and implementation of CMC regulatory strategy for small molecule investigational drugs in global... ...for CMC submissions and meetings. Strategize , plan, write, manage internal and external contributors and review region specific...Work at officeLocal areaRemote workWork from homeWorldwide$230k - $300k
...strategically partner with and advise senior management and the teams of Pharming Healthcare,... ...We develop and commercialize innovative therapies for rare and ultra-rare immunological... ...Choice of company provided mobile phone or cell phone stipend Additional information...Temporary workWork experience placementWork at officeRemote workFlexible hours- Regulatory and Medical Affairs - Sr. Manager Job Description: This position reports to the Franchise Cell Therapy Lead and is a key member of the US Medical Cell Therapy Team. The primary responsibility is to work across the Medical matrix teams, driving strategy and overall...
$263k - $360.93k
...novel, first in class targeted therapy for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) and to date, the... ...empower Company personnel to manage risk with clarity, integrity and... ...complying with its legal and regulatory obligations and undertake a continuous...Temporary workWork at officeRemote workFlexible hours$120k - $150k
...Supervisor to oversee day-to-day operations of its Stem Cell Lab. The role demands a Bachelor's Degree, NYS DOE... ...years of relevant experience. Responsibilities include managing staff, ensuring compliance with regulatory standards, and maintaining a high-quality work...Monday to Friday- ...Therapeutics Inc. in Warren, NJ seeks a Director/Senior Director of Regulatory Affairs to lead US and global regulatory strategy for YUVEZZI.... ...across multiple regions, collaborating with clinical, CMC, and commercial teams. The role requires 10+ years in regulatory...
$125k - $130k
...company committed to advancing transformative therapies for people with cancer and rare diseases.... ...candidate, TARA-002, an investigational cell-based therapy in development for the... ...least 2 days per week. Job Overview The Manager, Financial Planning and Analysis, provides...Local areaFlexible hours2 days per week$125k - $130k
...Manager, Financial Planning and Analysis New York, NY Company Overview Protara Therapeutics... ...committed to advancing transformative therapies for people with cancer and rare diseases.... ...candidate, TARA‑002, an investigational cell‑based therapy in development for the treatment...Local area2 days per week- Veeva, a mission-driven pioneer in life sciences industry cloud, is hiring a General Manager, CMC to own all aspects of building this new business. Reporting to the VP of Regulatory, you will lead a high‑performing team to deliver applications and capabilities, navigate...
$253k - $305k
...our best-in-class oncology and hematology therapies. In this high-impact role, you will... ...submissions through internal stakeholders. Manage quarterly and monthly GTN analyses and breakouts... ...with blastic plasmacytoid dendritic cell neoplasm (BPDCN) and to date, the only approved...Long term contractContract workTemporary workShift work$178k - $218k
...biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and live better lives. Our... ...cancer (NMIBC) disease spectrum. In 2024, our intravesical gene therapy achieved over 1,500 patients treated across the country...Full timeTemporary workWork at officeLocal areaRemote workWorldwideFlexible hours$125k - $300k
..., helping life sciences companies bring therapies to patients faster. As one of the fastest... ...on industry regulations and practices. Manages and oversees the QualityDocs specific partnerships... ...model and common standards, translating regulatory shifts into actionable product...Work at officeLocal areaRemote workWork from homeShift work3 days per week
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