CMC Regulatory Manager, Cell & Gene Therapies
Legend Biotech
Legend Biotech in Bridgewater, New Jersey, seeks a Manager, Regulatory CMC to drive global regulatory strategies for pipeline cell and gene therapies, with a strong focus on dossier authoring and cross-functional collaboration. You will coordinate submissions and maintain high-quality regulatory documents to support development and commercialization. The role requires 5+ years in biotechnology/pharma, with CMC experience, and familiarity with FDA, EMA, and ICH guidelines. A MS/PhD is preferred. #J-18808-Ljbffr Legend Biotech
- Legend Biotech in Somerset, New Jersey seeks a Manager, Regulatory CMC to lead global CMC regulatory strategies and drive high-quality regulatory submissions for cell and gene therapy programs. You will partner with Regulatory CMC Leads and cross-functional experts to...Suggested
- 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 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...Suggested
- Legend Biotech USA seeks a Manager, Regulatory CMC to support global regulatory strategies for pipeline programs, focusing on CMC dossier authoring and cross‑functional collaboration to advance development milestones. The role emphasizes coordinating with Regulatory CMC...Suggested
$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- ...company developing oncology therapies using its proprietary Deep Cyclic... ...and RAS-mutant non-small cell lung cancer, as well as... ...The Director/Senior Director, Regulatory CMC (Chemistry, Manufacturing, and... ...registration, and lifecycle management. A successful candidate will...Remote workFlexible hours
$276k - $414k
Job Title: Executive Director, Regulatory Affairs Strategy - Cell Therapy Available locations: NYC, NYGaithersburg, MDBoston, MASouth San Francisco, CASanta... ...stage through BLA submission, approval, and lifecycle management; may serve in a dual role as Franchise GRL and...Hourly payFull timeTemporary workWork at officeWorldwideFlexible hours3 days per week- Legend Biotech US seeks a Director, Regulatory Affairs in Somerset, NJ to lead global regulatory strategies and oversee submissions for the company’s cell therapy programs. You will interact with health authorities, coordinate cross-functional teams, and mentor staff to...
- ...Therapeutics, Inc. is seeking a Director, Regulatory Affairs - CMC to lead global CMC strategy for... ...and post-approval lifecycle management. You will guide cross-functional teams... ...ICH guidelines, and experience with gene/cell therapies. #J-18808-Ljbffr PTC Therapeutics,...
$193.5k - $243.6k
...Description Summary: The Director, Regulatory Affairs - CMC is responsible for leading... ...post-approval life cycle management of primarily biological... ...biological products (eg, gene therapy) in collaboration with Technical... ...a must; experience in gene/cell advanced therapy a plus....Temporary workWork at office- Legend Biotech seeks a Director of Regulatory Affairs to independently develop and coordinate global regulatory strategies for its cell therapy programs. Based in Somerset, NJ, the role will interact with health authorities and oversee regulatory filings to ensure timely...
- ...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
- ...the development of novel therapies, leveraging first-in-... ...The Senior Associate, Regulatory Affairs will be a key individual... ..., authoring and managing regulatory documents,... ...Clinical Development, CMC, Quality, Research, and... ...impacting oncology and cell therapy development Support...Flexible 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...
$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- ...specializing in Movement Disorders to lead clinical strategy for gene therapy programs. This role requires expertise in clinical trials and collaboration across teams to ensure patient safety and regulatory compliance. With over 6 years in relevant clinical roles and...
- Piper Companies is seeking a Senior Director, Quality & CMC Regulatory Strategy to join a global regulatory consulting and clinical development services leader. This remote permanent role places you as a senior advisor to biotechnology and pharmaceutical clients, guiding...Remote jobPermanent employment
$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- ...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
- 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
- PTC Therapeutics, Inc in New Jersey is seeking an Associate Director, Regulatory Affairs - CMC. This role involves leading global regulatory strategy for product development and collaboration with Technical Operations and Quality teams. The ideal candidate will have extensive...
- ...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
$130k - $164.6k
...Job Description Summary The Senior Manager, Global Clinical Regulatory Lead, is responsible for providing... ...regulatory strategy for drugs and gene therapies through conducting research, preparation... ...Analyze clinical, non-clinical and CMC development work in context with...Odd jobContract workTemporary workLocal area$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- Legend Biotech is seeking a Manager, Regulatory Project Management as part of the Regulatory team... ...the planning and execution of Cell & Gene Therapy development programs. Working closely... ...functional teams, including Research, CMC, Quality, Regulatory Affairs, Clinical...Permanent employmentFull timeContract workFor contractorsWork at officeLocal areaWorldwide
$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- ...delivering high-quality, affordable biologic therapies worldwide. As we expand in the United... ...Global Compliance on applicable legal, regulatory, and operational requirements. Partner... ...and research-related HCP engagements. Manage Risk Assessment and Regulatory Intelligence...For contractorsWorldwide
$152.24k - $161.2k
...Glassdoor, Indeed, Facebook, X, YouTube and Instagram. Position Summary We have an exciting opportunity to join our team as a Regulatory Standard Manager. In this role, the successful candidate This role supports regulatory activities, including survey readiness and...Work at office$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$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
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