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
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Director, Regulatory CMC: Post‑Approval Gene Therapy in Somerville, MA vacancy
$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...SuggestedFull timeWork at officeFlexible hours3 days per week- Lilly is seeking an experienced Regulatory CMC leader to develop and implement global CMC strategies for gene therapy programs. You will lead the preparation of CMC sections for IND/CTA, BLA/MAA submissions and serve as the primary liaison with major health authorities....Suggested
$195k - $330k
...convenient, highly effective therapies for patients with these... ...development and execution of global regulatory CMC strategies for degrader... ...late-stage development and approval with specific emphasis on late... ...trials through NDA/MAA and post-approval) regulatory CMC activities...Suggested- ...biopharmaceutical company developing oncology therapies using its proprietary Deep Cyclic... ...Primary Responsibilities The Director/Senior Director, Regulatory CMC (Chemistry, Manufacturing, and... ...to ensure timely submissions and approvals. • Prepare, review, and...SuggestedRemote workFlexible hours
IMMUNEERING CORPORATION
Cambridge, MA3 days ago $163.5k - $281.6k
...invite you to join us. Responsibilities Develop and implement comprehensive global regulatory CMC strategies for assigned gene therapy programs, including IND/CTA, BLA/MAA, and post-approval submissions. Lead and manage the preparation, authoring, and review of high-...SuggestedFull timeFor contractorsWork at officeFlexible hours$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...Minimum 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,...Full 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- ...developing transformative gene-based medicines... ...with the approval of CASGEVY® (exagamglogene... ...CRISPR-based therapy, approved for eligible... ...to the Head of Regulatory Affairs, you will... ...As the Regulatory CMC lead for these programs... ...: ~ Associate Director: ~12+ Years of...Contract workRemote work
CRISPR Therapeutics
Boston, MA3 days ago $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$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...$190.4k - $285.6k
Director, Regulatory Affairs CMCSkip to main content#Director, Regulatory Affairs CMC page is loaded## Director, Regulatory... ...Full timeposted on: Posted Yesterdayjob requisition... ..., review, and approval of CMC content for... ...of investigational therapies across a range of modalities...Summer workRemote workFlexible hours2 days per week$174.5k - $274.23k
...innovation and delivers transformative therapies to patients. By focusing R&D efforts... ...to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant management... ...management of regulatory change control and post‑approval activities at the site level....Minimum wageTemporary workLocal areaRemote workWorldwide$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- ...The Associate Director of Regulatory Affairs CMC will be responsible for developing, implementing... ...stage programs to secure approval of the manufacturing... ...access for Voyager's gene therapy products. These responsibilities... ..., BLAs and MAAs including post-approval supplemental...
Voyager Therapeutics, Inc.
Cambridge, MA3 days ago $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 hoursCrescent Biopharma
Waltham, MA2 days ago$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$195k - $330k
...convenient, highly effective therapies for patients with these conditions... ...an impact:Act as the global regulatory strategy lead for Kymera’s... ...closely with Clinical, CMC, Nonclinical, Quality, and Commercial... ...preferred but not required.Director: 8-10 years of Regulatory...Flexible hours- ...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
$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- Arbor Biotechnologies is seeking a Director of Regulatory Affairs to lead regulatory strategy across its portfolio, spanning preclinical and early clinical programs. You will serve as the global regulatory lead and primary contact with FDA and other authorities, guiding...
$129k - $153k
...committed to developing therapies that make a... ...Position Overview Regulatory leaders who leverage... ..., labeling and CMC GRAST members to ensure... ...development and approval in one or more key... ...the time of this posting. Individual base salary... ..., and cell and gene therapy to support...WorldwideRelocation packageBioSpace, Inc.
Waltham, MA2 days ago$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 workVerastem
Boston, MA2 days ago- ## Associate Director, CMC Quality Compliance and Inspection... ...Full timeposted on: Posted Todayjob requisition... ...:*** Knowledge of regulatory requirements and inspection... .... The company has approved medicines that treat... ...of investigational therapies across a range of modalities...Summer workRemote workFlexible hours2 days per week
- Sana Biotechnology, Inc. is seeking a Senior Director to lead the company’s IP strategy in cell and gene therapy. You will draft and prosecute patents, manage global portfolios, and guide landscape analyses. Collaboration with R&D and external counsel is essential to align...
$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$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$185k - $285k
Director, Regulatory Advertising and Promotion About Genetix Biotherapeutics... ...that's pursuing curative gene therapies to give patients and their... ...related to MLR reviews and approvals, as needed. Drive consistency... ...this job at the time of posting. We may ultimately pay more...Full timeWork at officeFlexible hours3 days per week
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Director, Regulatory CMC: Post‑Approval Gene Therapy. Be the first to apply!
Related searches
- regulatory contract Somerville, MA
- food regulatory Somerville, MA
- clinical research regulatory Somerville, MA
- regulatory law Somerville, MA
- regulatory Somerville, MA
- respiratory therapy manager Somerville, MA
- therapy Somerville, MA
- massage therapy instructor Somerville, MA
- therapy technician Somerville, MA
- therapy office Somerville, MA