Director, CMC Regulatory Strategy (Gene Therapy) - Remote
Neurogene Inc.
- Remote job
Neurogene Inc. seeks a Director, Regulatory Affairs CMC to lead regulatory strategy for our CNS gene therapy pipeline from our New York/remote hub. The role partners with Global Regulatory, Process Development, Quality, and Manufacturing to shape global CMC submissions and ensure compliance across IND/CTA/MAA pathways. The ideal candidate has 10+ years in Regulatory Affairs CMC, deep gene therapy knowledge, and a proven track record of leading multi‑year global submissions with FDA/EMA and other #J-18808-Ljbffr Neurogene Inc.
- Neurogene is seeking a Director, Regulatory Affairs CMC to lead regulatory strategy for our CNS gene therapy programs. You will support cross-functional teams across manufacturing... ...frameworks. Travel to Houston is expected; remote options may be available. #J-18808-Ljbffr...Remote work
- ...the limitations of conventional gene therapy in central nervous system... ...Overview - New York, Houston or Remote We are seeking a Director, Regulatory Affairs CMC, to join the Regulatory Affairs... ...plan, and execute the regulatory strategy to facilitate the achievement of...Remote workTemporary workShift work
- Genetix Biotherapeutics is looking for a Director, Regulatory CMC to lead global regulatory strategies for gene therapy products. This full-time hybrid position based in Somerville, Massachusetts involves managing post-approval regulatory strategies and ensuring compliance...SuggestedFull time
$170k - $220k
...Associate Director, Regulatory CMC – Solid Biosciences Charlestown, MA HQ Solid... ...on advancing a portfolio of gene therapy candidates targeting rare... ...development and regulatory strategy. We are seeking an Associate... ...including face to face and remote interactions. Excellent verbal...Remote workFull timeTemporary workFlexible hours$285k - $320k
...quality of work. What You'll Do Lead CMC regulatory strategy and execution across development and post... ...You'll Work This is a U.S.-based remote role that will require quarterly, or as... ...benefits Expanded mental health support (therapy and coaching resources) Hybrid work...Remote workWork at officeFlexible hours$189k - $246k
...Department: 107000 Regulatory Location: San Diego, USA- Remote Be a part of a global... ...life-changing therapies to people living with... ...Position Summary: The Director, Regulatory Affairs Strategy is responsible for developing... ..., Biostatistics, CMC, Quality, Nonclinical...Remote workTemporary workLocal areaWeekend work- BioSpace is seeking a Senior Director of Regulatory Affairs in Boston. The role involves planning and executing regulatory strategies for gene-editing programs, managing submissions, and serving as a key contact with regulatory authorities. This position requires a Bachelor...
$174.5k - $274.23k
...and delivers transformative therapies to patients. By focusing R... ...patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant... ...communicate regulatory strategy to drug development,... ...following Takeda’s Hybrid and Remote Work policy. Takeda Compensation...Remote workMinimum wageTemporary workLocal areaWorldwide- ...required to bring novel therapies to patients who need... .... Job Summary The , CMC Global Regulatory Affairs is... ...Regulatory Affairs and may be remote or based at Liquidia... ...regulatory submission strategies by working closely with... ...a plus. For Director, minimum of 10-year CMC...Remote workContract workShift work
$177k - $278.08k
...delivers transformative therapies to patients. By... ...is within the Global Regulatory Affairs (GRA) Chemistry... ...Manufacturing & Controls (CMC) and Devices organization... ...the regulatory CMC strategy and leads the execution... ...following Takeda's Hybrid and Remote Work policy....Remote workMinimum wageTemporary workLocal areaWorldwide$199.95k - $242.3k
## Director, Regulatory CMC - Cell TherapyMadison - Giralda - NJ - USFind out how... ...breakthroughs in cell therapy, this is work that transforms... ...effective global regulatory strategies in coordination with clinical... ...centers. Employees in remote-by-design or lab-based roles...Remote workHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaFlexible hoursShift work$210k - $235k
...development, commercial strategy, and beyond.... ...beyond one indication—a therapy that has already shown... ...and geographies. The Director, Regulatory Strategy provides global... ...D, Clinical, Quality, CMC, Commercial, and represents... ...authorities . Remote role; occasional travel...Remote workWorldwideFlexible hours$270k - $285k
...biotechnology firm in Somerville, Massachusetts, is looking for a Senior Director, Regulatory CMC. This role is pivotal in defining and executing global CMC regulatory strategies for gene therapy products while ensuring compliance. Responsibilities include driving CMC...Full time$238k - $374k
...delivers transformative therapies to patients. By focusing... ...worldwide. As Executive Director, Global Regulatory Affairs CMC Devices and Drug‑Device Combination... ...and robust regulatory strategies for medical devices and... ...Takeda's Hybrid and Remote Work policy. Takeda Compensation...Remote workMinimum wageFull timeTemporary workWork at officeLocal areaWorldwide- ...Description The Senior Manager Regulatory Affairs, Chemistry,... ...and Controls (CMC) works with internal and... ...including mAb, ADC and cell & gene therapies. The role prepares CMC regulatory strategies that enable first‑pass... ...in office & 2 days remote) from the Waltham, MA &...Remote workWork at office
- ...portfolio. Senior Manager, Regulatory Affairs - Chemistry,... ...and Controls (CMC) The Senior Manager works... ...mAb, ADC, and cell & gene therapies, to patients. The role... ...prepares CMC regulatory strategies that enable first‑pass... ...days in office & 2 days remote) at the Waltham, MA &...Remote workWork at office
$200k - $235k
Ray Therapeutics seeks a Director of Regulatory Affairs - CMC based in Berkeley, CA. This leader will develop global regulatory strategies for gene therapy programs while ensuring compliance and quality submissions. The position requires a strong background in regulatory...- ...of adoptive T-reg therapies cell for autoimmune... ...an experienced Regulatory professional to manage... ...SSF headquarters. Remote US candidates are... ...global regulatory strategies for the... ...counterparts (Reg CMC and Reg Ops) and collaborate... ...ideally in cell & gene therapy Well-versed...Remote work
$204k - $245k
...of a company that’s pursuing curative gene therapies to give patients and their families more... ...every challenge with radical care. The Director, Regulatory CMC is responsible for leading execution of global CMC regulatory strategies for approved and late‑stage gene therapy...Full timeWork at officeFlexible hours3 days per week$132k - $172k
Department: 107000 Regulatory Location: San Diego, USA — Remote Be a part of a global team that... ...deliver life-changing therapies to people living with... ...Summary The Senior Manager, CMC Regulatory Affairs is... ...of global CMC regulatory strategies to support clinical development...Remote workTemporary workWorldwide$133.2k - $172.37k
...pioneering personalized CAR T‑cell therapies have changed the paradigm.... ...approach with two days of remote working and three days... ...preparation and submission of CMC regulatory filings (INDs, CTAs, BLAs, MAAs... ...of global CMC regulatory strategies under guidance of senior staff...Remote workWork at officeLocal areaRelocationFlexible hours$144.38k - $240.63k
...Summary You will lead Chemistry, Manufacturing and Controls (CMC) regulatory strategy for development and lifecycle activities. You will work... ...States, with a mix of in‑office days for team collaboration and remote days for focused work, as agreed with your manager. Annual...Remote workWork at officeLocal areaWorldwide$200k - $250k
Senior Director, Regulatory Strategy Consulting 4 days ago - Be among the first 25 applicants... ...at scale. Work Location: Remote position. Travel may be... ..., and/or regulatory CMC. Experience across multiple... ...small molecules, cell and gene therapy, oligonucleotides, peptides...Remote workFull time- ...Summary You will lead Chemistry, Manufacturing and Controls (CMC) regulatory strategy for development and lifecycle activities, working with... ...Expect a mix of in‑office days for team collaboration and remote days for focused work, as agreed with your manager. Benefits...Remote workWork at officeLocal areaWorldwide
$116k - $151k
Department: 107000 Regulatory Location: San Diego, USA- Remote Be a part of a global team that... ...deliver life‑changing therapies to people living with rare... ...implementation of global regulatory strategies from development through... ...Clinical, Nonclinical, CMC, Regulatory Operations,...Remote workContract workTemporary work- ...am leading a search for a Senior Director, Global Regulatory Clinical Strategy at a commercial-stage biopharmaceutical... ...small molecules, biologics, and gene therapy. This is a highly visible... ...Clinical Development, Nonclinical, CMC, Commercial, and Executive Leadership...
- Role Overview The Senior Director, Regulatory Affairs serves as the regulatory lead for nonclinical... ...‑toxicology) and IND‑enabling strategy for cell and gene therapy programs regulated by FDA/CBER.... ...and provides regulatory support to CMC for lentivector‑enabled products. The...Relocation package
$270k - $285k
...of a company that's pursuing curative gene therapies to give patients and their families more... ...care. Position Description The Senior Director, Regulatory CMC is responsible for defining and executing global CMC regulatory strategy for approved and late-stage gene therapy...Full timeWork at office3 days per week$199.95k - $242.3k
Bristol Myers Squibb is seeking a Director, Regulatory CMC to oversee multiple development projects and represent the organization on cross-functional teams. This role is essential in ensuring compliance with global regulatory guidelines and managing the growth of direct...$130k - $200k
...apply for the Associate Director Regulatory Affairs role at Tonix... ...develop regulatory strategies and submission plans.... ...office or can be a remote-based position. Act as... ...Regulatory Affairs, Gene Therapy United States $11,000... ...Associate Director, CMC Regulatory Affairs United...Remote workFull timeTemporary workWork at officeLocal areaFlexible hours
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Director, CMC Regulatory Strategy (Gene Therapy) - Remote. Be the first to apply!
- compliance director New York, NY
- director quality compliance New York, NY
- healthcare compliance manager New York, NY
- quality regulatory manager New York, NY
- regulatory affairs manager pharmaceutical New York, NY
- senior director regulatory affairs New York, NY
- sox compliance manager New York, NY
- compliance audit manager New York, NY
- director security & compliance New York, NY
- senior regulatory manager New York, NY

