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
$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...SuggestedFull time$204k - $245k
...company that’s pursuing curative gene therapies to give patients and their... ...with radical care. The Director, Regulatory CMC is responsible for leading... ...regulatory strategies for approved and late‑stage gene therapy... ...development and delivery of post‑approval regulatory strategies...SuggestedFull timeWork at officeFlexible hours3 days per week$270k - $285k
...company that's pursuing curative gene therapies to give patients and their... ...Description The Senior Director, Regulatory CMC is responsible for defining... ...regulatory strategy for approved and late-stage gene therapy... ...efficient implementation of post-approval manufacturing, analytical...SuggestedFull timeWork at office3 days per week- The Director of Regulatory Affairs (Rare Disease) will lead global... ...NDA/MAA submissions and approval. This individual will... ...Track, Breakthrough Therapy) Act as regulatory contact... ...Partner closely with CMC, Clinical, and... ...preferred Experience in gene therapy, biologics, or...Suggested
- ...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 assigned product...SuggestedFull timeLocal areaWorldwide
$174.5k - $274.23k
A leading biopharmaceutical company is seeking a Director Regulatory Site CMC in Boston, MA. The role focuses on regulatory change control and post-approval activities, ensuring compliance across diverse modalities. Candidates should have over 10 years of experience in...- ...innovation and delivers transformative therapies to patients. By focusing R&D... ...therapies to patients worldwide. The Director, Regulatory Site CMC ensures efficient and compliant management... ...of regulatory change control and post‑approval activities at the site level....Local areaWorldwide
$170k - $220k
...Associate Director, Regulatory CMC – Solid Biosciences Charlestown, MA HQ Solid Biosciences is a precision genetic medicine company focused on advancing a portfolio of gene therapy candidates targeting rare neuromuscular and cardiac diseases, including Duchenne muscular...Full timeTemporary workRemote workFlexible hours$238k - $374k
...delivers transformative therapies to patients. By focusing... ...worldwide. As Executive Director, Global Regulatory Affairs CMC Devices and Drug‑Device Combination... ...and minimizing time to approval/clearance. Establish... ...evidence, labeling/UDI, post‑market signals)....Minimum wageFull timeTemporary workWork at officeLocal areaRemote workWorldwide$212k - $333.19k
...delivers transformative therapies to patients. By focusing... ...About the Role As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug‑Device Combinations... ...authorities. Review and approve medical device... ...File submissions, global post approval submissions, etc...Minimum wageFull timeTemporary workLocal areaRemote workWorldwideNight shift- ...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...Work at officeLocal areaRemote 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...
- ...commercially minded Senior Director or Executive Director of US Regulatory Strategy to join... ...and complex therapies. Key... ...risk assessment, CMC, nonclinical and clinical... ...requirements, labeling, and post-approval strategy. Lead... ...and cell and gene therapies. Strong...
$238k - $374k
...organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four... ...changing therapies to patients worldwide. As Executive Director, Global Regulatory Affairs CMC Early Development you will provide strategic leadership...Full timeTemporary workLocal areaWorldwide- Takeda in Boston, MA seeks a Director of Regulatory Site CMC to lead post‑approval change management across multiple sites, guiding submissions and aligning with global regulatory expectations. You will apply ICH Q12 principles, drive standardized processes, and explore...
- Senior Manager/Associate Director, Global Regulatory Affairs CMC About the Opportunity A growing biotechnology company is seeking an experienced Senior... ...and commercialization of innovative biologic therapies. This individual will play a key role in developing and...
$207k - $253k
...Rezdiffra is the first and only medication approved by both the FDA and European Commission... ...provides strategic, tactical and operational regulatory CMC leadership to support clinical trial applications, market registrations and post-approval submissions, along with managing...Full timeLocal areaFlexible hours$196k - $240k
...Facebook . Role Summary The Director, Regulatory Affairs – Chemistry,... ..., and Controls (CMC) is responsible for defining... ...and beyond product approval. This role plays a... ...IND, IMPD, BLA/MAA, and post-approval lifecycle management... ...to the advancement of therapies for patients with...Local areaWorldwide- ...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
$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$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- ...strategic and experienced Senior Director of Regulatory Affairs to lead and execute... ...through BLA submission and approval. You will manage a small... ...teams (Clinical, Nonclinical, CMC, Biostatistics, Clinical... ...pathways (e.g., Breakthrough Therapy, Fast Track, Accelerated Approval...Work at officeLocal area3 days per week
- ...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
- ...Summary You will lead Chemistry, Manufacturing and Controls (CMC) regulatory strategy for development and lifecycle activities, working... ...through continuous change and improvement. Experience in major post‑approval filing activities (significant manufacturing change or key...Work at officeLocal areaRemote workWorldwide
$210k - $235k
...beyond one indication—a therapy that has already shown... ...and geographies. The Director, Regulatory Strategy provides... ...product development, approval, and lifecycle management... ...D, Clinical, Quality, CMC, Commercial, and represents... ...commercialization and post‑approval lifecycle...Remote workWorldwideFlexible hours$211.5k - $258.5k
...category-leading precision therapies to transform the lives of people... ...fully. Job Summary The Director, Regulatory Strategy - Global... ...ensuring alignment with clinical, CMC, and non‑clinical development... ...from pre‑IND through post‑approval. Extensive experience preparing...Local areaFlexible hours2 days per week$238k - $294k
...a company that's pursuing curative gene therapies to give patients and their families... ...care. Position Description The Sr. Director, Regulatory Affairs Advertising, Promotion and Labeling... ...labeling, including pre‑ and post‑ approval updates. Drive development and maintenance...Full timeWork at officeFlexible hours3 days per week$235k - $260k
...innovative, patient-friendly therapies. Our approach is rooted in... ...and strategic Senior Director of Regulatory Affairs Advertising/Promotion... ...of the MLR team, review and approve: Unbranded/disease state materials... ...outside of the posted range. #J-18808-Ljbffr ApnimedWork at office$220k - $290k
...treatment resistance. The FDA approval of AVMAPKI FAKZYNJA CO... ...delivered the first therapy specifically for women... ....S. and are exploring regulatory pathways for Europe... ...plans. The Senior Director, Regulatory Affairs has... ...development program. Guide CMC, nonclinical and...Temporary workFor contractorsWork at officeWeekday work- Associate Director / Director, Global Regulatory Affairs CMC About the Opportunity A growing biopharmaceutical organization... ..., BLAs, MAAs, variations, and post-approval submissions. Provide strategic... .... Exposure to innovative therapies and complex regulatory challenges...
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