Director, Regulatory CMC: Post‑Approval Gene Therapy
Genetix Biotherapeutics
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 with global standards. Ideal candidates will have at least 10-12 years in biopharmaceuticals and a strong background in CMC regulatory affairs, demonstrating exceptional communication and project management skills. #J-18808-Ljbffr Genetix Biotherapeutics
$204k - $245k
...Director, Regulatory CMC Somerville, MA At Genetix Biotherapeutics every... ...company that's pursuing curative gene therapies to give patients and their... ...regulatory strategies for approved and late-stage gene therapy... ...and delivery of post-approval regulatory strategies...SuggestedFull timeWork at officeFlexible hours3 days per week$163.5k - $281.6k
...highly experienced and strategic Director/Senior Director, Regulatory CMC to lead and execute regulatory CMC... ...strategies for our cutting-edge gene therapy portfolio. This role will be critical... ...including IND/CTA, BLA/MAA, and post-approval submissions.Lead and manage the...SuggestedFor contractorsWork at officeFlexible hours- ...Associate Director, Regulatory Affairs CMC Founded over a decade ago, CRISPR Therapeutics... ...developing transformative gene-based medicines for... ...historic milestone with the approval of CASGEVY® (exagamglogene... ...'s first CRISPR-based therapy, approved for eligible patients...SuggestedContract workRemote work
$177k - $278.08k
...innovation and delivers transformative therapies to patients. By focusing R&D... ...role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and... ..., registration and post-approval strategies for their assigned...SuggestedMinimum wageTemporary workLocal areaRemote workWorldwide$241k - $332k
About This Role:As the Head of Regulatory CMC - Biologics & Advanced Therapy Medicinal Products (ATMP), you will lead... ...oversight to ensure timely approvals and lifecycle progression. Your leadership... ...questions.Provide oversight for post-approval lifecycle activities,...SuggestedFull timeTemporary workLocal area$182k - $275k
...quality, science-based, and compliant regulatory CMC deliverables for assigned program(s),... ...applications, marketing applications, post-approval submissions, and health authority responses... ...more patients and developing novel therapies for other rare neuroendocrine diseases...Work at office$238k - $374k
...delivers transformative therapies to patients. By focusing... ...patients worldwide.As Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device... ...and minimizing time to approval/clearance.Establish best... ...evidence, labeling/UDI, post-market signals). Anticipates...Minimum wageTemporary workWork at officeLocal areaRemote workWorldwide$212k - $333.19k
...delivers transformative therapies to patients. By focusing... ...patients worldwide. As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug‑Device... ...authorities. Review and approve medical device... ...File submissions, global post‑approval submissions, etc...Minimum wageFull timeTemporary workLocal areaWorldwideNight shift$290k - $323k
...build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s clinical-stage pipeline... ...the Company on LinkedIn and X. Lead and/or oversee global regulatory CMC submissions (e.g., INDs, CTAs, BLAs, MAAs etc.) through product...Temporary workFor contractorsFlexible hours$218.06k - $327.09k
Job Title: Senior Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg, MDBoston, MASouth... ...clear, competitive pathways to approval and labeling. You will shape strategy... ...objectives with clinical, CMC, safety and commercial strategies....Hourly payFull timeTemporary workStart working todayWork at officeFlexible hours3 days per week$212k - $318k
...Cystic Fibrosis (CF), Casgevy, a gene therapy for sickle cell disease and... ...However, there are very few approved treatments that address a... ...faster than ever before.The Director, T1D will serve as a T1D... ...for this job at the time of posting. This role is eligible for an...Full timeSummer workRemote workFlexible hours2 days per week$268.2k - $402.2k
Job DescriptionGeneral Summary:The Executive Director, Regulatory Strategy will serve as a seasoned regulatory leader with expert technical and... ...regulatory strategy for multiple projects in development (from FIH to post marketing application stage) within the T1D portfolio,...Full timeSummer workLocal areaRemote workFlexible hours2 days per week$190.4k - $285.6k
...DescriptionGeneral Summary:The Director, Chemistry Manufacturing Controls (CMC) leads a Regulatory CMC team responsible for... ...Oversees preparation, review, and approval of CMC content for global regulatory... ...for this job at the time of posting. This role is eligible for an...Full timeSummer workRemote workFlexible hours2 days per week$189k - $246k
...Department: 107000 Regulatory Location: San... ...life-changing therapies to people living with... ...Summary: The Director, Regulatory... ...Affairs, Biostatistics, CMC, Quality, Nonclinical... ..., Accelerated Approval, Priority Review,... ...the date of this posting and may be modified...Temporary workLocal areaRemote workWeekend work- ...The Senior Manager Regulatory Affairs, Chemistry, Manufacturing... ...and Controls (CMC) works with internal... ...including mAb, ADC and cell & gene therapies. Prepares CMC... ...that enable first pass approvals. Develops and manages... ...more or less than the posted range. This range may...Full timeWork at officeLocal areaRemote work
$200k - $220k
...Director/ Senior Director, Regulatory CMC Join Us in Tackling Autoimmune Disease at Its Root At Vor, we believe... ...beyond one indication – a therapy that has already shown consistent... ...from early development to pre‑ and post‑approval submissions and product lifecycle...Contract workWorldwideFlexible hours$200k - $300k
...develops, and delivers life-changing therapies for people with serious diseases... ...LinkedIn. Summary of Position The Director or Senior Director, Regulatory Strategy, reporting to the SVP, Global... ...of regulatory requirements and approvals to inform regulatory strategies and...Work at officeLocal areaShift work$207k - $253k
## Director, Regulatory Affairs CMCApplylocations: MA - Waltham - Officetime type: Full timeposted on: Posted 3 Days Agojob requisition id: JR\_000763Madrigal... ...and only medication approved by both the FDA and European... ...and operational regulatory CMC leadership to support...Minimum wageFull timeLocal areaFlexible hours$207k - $253k
...associated steatohepatitis (MASH). This role provides strategic, tactical and operational regulatory CMC leadership to support clinical trial applications, market registrations and post‑approval submissions, and manages day‑to‑day regulatory CMC activities for assigned...Full timeFlexible hours$196k - $240k
...communities. Role Summary The Director, Regulatory Affairs - Chemistry,... ..., and Controls (CMC) is responsible for... ...through and beyond product approval. This role plays a... ...IND, IMPD, BLA/MAA, and post‑approval lifecycle... ...to the advancement of therapies for patients with serious...Local areaWorldwide- ...Biotechnologies, based in Cambridge, MA, is seeking a Manager, Regulatory Affairs to support an expanding gene editing programs portfolio. You will lead regulatory... ...Cambridge area, with collaboration across Clinical, CMC, Quality, and Program Management. Strong writing and...
- ...pipeline. This individual will work closely with the CMC, Quality Assurance, Clinical Drug Supply, and Regulatory Affairs teams to ensure the successful planning,... ...registration, marketing authorization, and post‑approval activities. Proven experience preparing and reviewing...Flexible hours
$159k - $195k
...Role Summary: The Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) is accountable for executing... ...development through and beyond approval. This position supports Dyne's... ...pay for this role at the time of posting. Individual compensation...Local area$160.8k - $201k
.... In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne. We’re... ...of the Role The Associate Director, Regulatory Labeling and Disclosures, will be... ...registration, maintenance and results posting on Health Authority-managed databases...Full timeWork at officeLocal areaImmediate startWorldwide$182k - $208k
...inclusive, and positive company culture. Job Title: Associate Director, Regulatory CMC (Biologics) Location: Hybrid – Waltham, MA .... ...various stages of clinical development and marketing approvals Successful track record of managing interactions with...Full time$170.9k - $231.3k
Overview The Associate Director, Regulatory Affairs CMC Development is responsible for developing and implementating global CMC regulatory strategies... ...range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors...Full timeTemporary workWork at officeLocal areaFlexible hours$276k - $414k
Job Title: Executive Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg, MDBoston,... ...therapies and turn science into approved medicines? Do you see yourself steering... ...and submission, major post-submission interactions, and complex...Hourly payFull timeTemporary workWork at officeWorldwideFlexible hours3 days per week$177k - $278.08k
...and delivers transformative therapies to patients. By focusing R&... ...to patients worldwide.The Director Global Regulatory Affairs, Neuroscience is responsible... ...all US FDA submissions and approvals of project(s) of... ...of FDA, EU, Canada, ROW and post-marketing a plus. Understand...Minimum wageTemporary workLocal areaRemote workWorldwide$134.2k - $202.2k
...MassachusettsShift: Department: HC-RD-RCD1 Reg CMC LM Marketed 1Recruiter: Sarah EllisThis... ....Your Role:The Senior Manager Regulatory CMC (RCMC) is responsible and accountable... ...documents, Annual reports, IB CMC, ATOs up to approval.Provides the Global Regulatory CMC advice...Local areaImmediate startWorldwide$238k - $374k
...all 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...Minimum wageTemporary workLocal areaRemote work
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