Director, Regulatory CMC - Cell & Gene Therapy
BioSpace
Legend Biotech in Somerset, NJ, is seeking a Director of Regulatory CMC to lead global regulatory strategies for late‑stage and post‑approval programs. You will guide cross‑functional teams, manage clinical and commercial lifecycle activities, and interact with Health Authorities to ensure compliant submissions. The role requires an advanced life sciences degree and 10+ years in biotech/pharma, including Regulatory CMC and cell/gene therapy experience. #J-18808-Ljbffr BioSpace
- Vertex Pharmaceuticals LLC seeks a Regulatory CMC Manager to drive international CMC submissions and regulatory strategies for cell and gene therapy programs. You will collaborate with cross-functional teams to ensure regulatory requirements are integrated throughout the...Suggested
- Legend Biotech, based in Somerset, NJ, seeks a Director of Regulatory CMC to lead global strategies for late-stage and post-approval lifecycle management, driving alignment with manufacturing and development teams. You will act as the primary Regulatory CMC representative...Suggested
- Miltenyi Biomedicine seeks a Director, Regulatory Affairs with a CMC focus to lead regulatory CMC activities for cell therapy programs across the US, Canada, and other regions. The role partners with Bioindustry and Biotec to craft regulatory strategies supporting clinical...Suggested
$193.63k - $254.14k
...are advancing the next generation of cell therapy through a portfolio of innovative technologies... .... Legend Biotech is seeking a Director, Regulatory CMC as part of the Regulatory Affairs... ...experience supporting biologics, cell and gene therapy. Direct experience with CAR‑T...SuggestedPermanent employmentFull timeTemporary workFor contractorsLocal areaWorldwideFlexible hours- Legend Biotech is seeking a Director, Regulatory CMC as part of the Regulatory Affairs team based in Somerset, NJ. The role leads global CMC regulatory strategies for late-stage development and post-approval lifecycle management, reporting to the Regulatory Affairs head...Suggested
$193.5k - $243.6k
...Site: Job Description Summary: The Director, Regulatory Affairs - CMC is responsible for leading global regulatory... ...primarily biological products (eg, gene therapy) in collaboration with Technical... ...is a must; experience in gene/cell advanced therapy a plus. Special knowledge...Temporary workWork at office- Legend Biotech is seeking a Director, Regulatory Affairs as part of the Regulatory Affairs team based in Somerset, NJ. You will lead the global... ...regulatory filings for INDs, CTAs, and BLAs to support cell therapy programs. The role requires a PharmD or PhD with 7+ years of...
- 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...
- ...biopharmaceutical company developing oncology therapies using its proprietary Deep Cyclic... ...cancer and RAS-mutant non-small cell lung cancer, as well as additional... ...Primary Responsibilities The Director/Senior Director, Regulatory CMC (Chemistry, Manufacturing, and...Remote workFlexible hours
$168.37k - $220.99k
...are advancing the next generation of cell therapy through a portfolio of innovative technologies... ...myeloma. Legend Biotech is seeking a Director, Regulatory Affairs as part of the Regulatory... ...Experience in cell and gene therapy is a plus Experience in drug development...Permanent employmentFull timeTemporary workFor contractorsLocal areaWorldwideFlexible hours- Neurogene Inc. in New York City or remote is seeking a Manager, Regulatory Affairs to lead regulatory strategies and high‑quality... ...communication to drive efficient filings and program advancement in a fast‑paced gene therapy environment. #J-18808-Ljbffr Neurogene Inc.Remote job
- ...address the limitations of conventional gene therapy in central nervous system disorders.... ..., NY Or Remote. Reports To the Senior Director, Regulatory Affairs Individual Contributor Role The... ...in good standing Monitor the evolving cell and gene therapy regulatory landscape,...Contract workRemote workShift work
- Legend Biotech US is seeking a Director, Regulatory CMC based in Somerset, NJ, to lead global CMC regulatory strategies for late-stage and post-approval programs within Regulatory Affairs. You will influence development and manufacturing strategies and serve as the primary...
- Travere Therapeutics is seeking a Director, Technical Operations (Biologics CMC Technical Writing) to lead the preparation of regulatory CMC documentation, including BLA submissions. You will drive the strategy with Regulatory Affairs and SMEs, delivering rigorous, regulator...
- Legend Biotech in Somerset, NJ is seeking a Director, Regulatory CMC to lead global regulatory strategies across late-stage development and post-approval lifecycle for commercial products. You will provide strategic regulatory leadership to cross-functional teams, interact...
- ...investigations and related records. The role ensures product quality in compliance with regulations and company guidelines at the Summit Cell Therapy Facility. The position requires strong data interpretation, investigative writing, and cross-functional collaboration with...Monday to FridayDay shift
$140.2k - $390.6k
Overview IQVIA is seeking a Director, Managed Access Regulatory Strategy to help build a regulatory strategy offering supporting patient access programs for investigational therapies outside of traditional clinical trial settings. This role will support Expanded Access...Full timePart timeImmediate startWorldwide$75 - $85 per hour
...company focused on developing cell therapies for patients suffering from... ...and driven Manager of Regulatory Affairs to join our regulatory... ...Consultant Reports to: Executive Director, Regulatory Affairs Location... .... Experience with cell or gene therapy regulatory affairs....Hourly payContract workRemote work$215k - $268.55k
...Head of US Compliance Risk and Assurance (Sr. Director) Reports to Chief Compliance Officer, Oncology... ...Tagraxofusp is a novel, first in class targeted therapy for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) and to date, the only approved treatment...Temporary workLocal areaFlexible hours$247.4k - $309.2k
...urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed... ...information on SMPA, visit our website Senior Director, Medical Strategy, Hematologic... ...RWE, Medical Information, Commercial, Regulatory, and other internal stakeholders to ensure...Work at officeRemote workFlexible hours- 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...
$156.9k - $247k
...organization committed to advancing innovative therapies for patients with cancer. We have an... ...treatment ecosystem. Reporting to the Director, Patient Support Strategy Lead, the... ...of advanced therapies, including cell therapy, gene therapy, radioligand therapy, individualized...For contractorsWork at officeLocal areaRemote workFlexible hours- Job Title: Director, Regulatory Affairs, Pharmaceuticals Employment Type: Permanent Location: 300 Welsh Road, Building 5, Suite 201, Horsham, PA... ...throughout the product lifecycle, including Development, CMC, Labeling, Promotion, Commercialization, and Operations. Must...Permanent employment
- ...delivering high-quality, affordable biologic therapies worldwide. As we expand in the United... ..., proactive, business-minded **Director, U.S. Compliance** to establish and lead... ...Global Compliance on applicable legal, regulatory, and operational requirements. Partner with...For contractorsWorldwide
- ...develop and deliver life-changing therapies to people living with rare... ...Summary: The Executive Director, Translational Medicine and Pediatric... ...strategies, pediatric regulatory commitments, and associated clinical... ...strategies. Work with CMC and device teams to address age...Remote work
- ...Senior Director, Regulatory Affairs - Hybrid NYC Area Key Responsibilities Develop and execute regulatory strategies supporting clinical development and future product approvals. Lead and support preparation and submission of regulatory filings, including INDs...Full time
$170k
...About Us Optima Partners is a global compliance and regulatory consulting firm trusted by leading financial institutions worldwide. With... ...regulatory and compliance matters. We are seeking a Director to join our New York office and play a leadership role in our...Full timeWork at officeWorldwide$125k - $300k
...pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS... ...evolve the quality content model and common standards, translating regulatory shifts into actionable product requirementsBe a thought leader...Work at officeLocal areaRemote workWork from homeShift work3 days per week$165k - $200k
...with a growing team across the U.S. and Europe. About the Role Corgi Insurance Services, Inc. is seeking a Director of Government & Regulatory Affairs to lead our relationships with state Departments of Insurance (DOIs) nationwide. You will monitor and shape insurance...Full time$116k - $246k
Director, Cybersecurity Regulatory Engagement (1LOD) At BNY, our culture allows us to run our company better and enables employees’ growth and success. As a leading global financial services company at the heart of the global financial system, we influence nearly 20% of...Temporary workWorldwideFlexible hours
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