Remote CMC Regulatory Lead - Gene Therapy
Astellas Pharma
Astellas in Westborough, MA is seeking a senior Regulatory CMC leader to develop and drive global CMC regulatory strategy and submissions. You will collaborate with RA, QA, and technical teams across regions to ensure compliant, timely registrations for NMEs and changes.
This role requires a BS in Biology or equivalent with 10 years in the pharma industry and at least 6 in Regulatory Affairs or CMC, strong English communication, and experience with EU/US/Japan regulations.
#J-18808-Ljbffr$144.06k - $205.8k
...provide transformative therapies in disease areas... ...role in the Regulatory Affairs department... ...Manufacturing and Controls (CMC) aspects of... ...as a CMC regulatory lead for highly complex... ...Preferred Qualifications:Gene and Cell Therapy Experience... ...Westborough, MA. Remote work from anywhere...Remote workRegulatoryWork at officeLocal areaWork from homeWorldwide- ...Atsena seeks an Associate Director/Director, CMC Regulatory Affairs to lead global regulatory strategy for gene therapy programs from early research to commercialization. The role interfaces with process development, analytical development, manufacturing, and quality...Regulatory
- CRISPR Therapeutics, Inc. is seeking an Associate Director, Regulatory Affairs CMC to lead regulatory CMC efforts for a portfolio of gene-based medicines. You will collaborate with cross-functional teams and partners to devise innovative regulatory strategies while coordinating...RegulatoryContract workWorldwide
- Orchard Therapeutics is seeking a US Regulatory Lead to drive regulatory strategy and execution for ex-vivo gene therapy programs. This role reports to the Executive Director... ...regulatory certification. This role offers remote work with a US market focus and...Remote workRegulatory
- Senti Biosciences seeks a senior regulatory leader to own and drive CMC regulatory strategies for a complex cell therapy portfolio. You will coordinate global submissions, interact with agencies, and guide cross-functional teams in a fast-paced environment in South San...Regulatory
- GeneFab seeks a Program Manager to drive cell and gene therapy CRDMO programs within an IPD framework, supporting the full product development lifecycle from design to regulatory submission. You will lead cross-functional teams, co-own outcomes with sponsors and partners...Regulatory
$177k - $278.08k
...delivers transformative therapies to patients. By... ...role is within the Global Regulatory Affairs (GRA) Chemistry... ...Manufacturing & Controls (CMC) and Devices organization... ...the GRA CMC Franchise Lead for TAK-079 Independently... ...Takeda's Hybrid and Remote Work policy. Takeda Compensation...Remote workRegulatoryMinimum wageFull timeTemporary workLocal areaWorldwide- 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....Regulatory
- 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...RegulatoryFull time
- Sentibio in South San Francisco seeks a regulatory affairs leader to drive CMC strategies for a complex cell therapy program. You will shape global regulatory CMC plans, coordinate... ..., with extensive experience in biologics and gene/cell therapy. Some travel (approx. 20%) is...Regulatory
- Ray Therapeutics, Inc. is seeking a Director, Regulatory Affairs CMC to lead global CMC regulatory strategies for clinical-stage gene therapy programs. You will collaborate across CMC, Technical Operations, Quality, and Clinical teams to ensure timely, compliant regulatory...Regulatory
- Rocket Pharmaceuticals, Inc. is seeking a Director, Regulatory Affairs - CMC to lead global CMC regulatory strategy for its gene therapy programs. You will coordinate with internal and external stakeholders to drive submissions and ensure compliance across US, EU, and...RegulatoryFull time
- ...DirectorJob Description - CMC Team Leader, Sr.... ...targeted cell therapies designed specifically... ...diseases. The lead CARTA (Chimeric Antigen... ...OperationsLocation: [Remote]Department:... ...Manufacturing, Quality, Regulatory Affairs, Supply Chain... ..., with cell and gene therapy experience...Remote workRegulatory
- NewAmsterdam Pharma Corporation is seeking a Senior Manager CMC Regulatory Affairs to oversee global CMC regulatory strategies for clinical development programs and marketing applications. The role is remote and emphasizes collaboration with various departments to ensure...Remote jobRegulatory
$258.68k - $313.46k
...breakthroughs in cell therapy, this is work that transforms... ...us.Sr Director, Global Regulatory Strategy,... ...staff as Global Regulatory Lead and US Regional Regulatory... ...areas – Drug Development/CMC/Pharmtox/Biopharmaceutics... ...centers. Employees in remote-by-design or lab-based...Remote workRegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaFlexible hoursShift work- Associate Director, Regulatory Affairs CMC (Project Management) Job... ...Therapeuticsis a leading biopharmaceutical company... ...transformative gene-based medicines for serious... ...s first CRISPR-based therapy, approved for... ...workplace that balances remote work flexibility with...Remote workRegulatoryContract work
$227.42k - $275.58k
...expertise and resources of a leading innovator in oncology. Our... ...transformative radiopharmaceutical therapies that offer new hope for... ..., Clinical Pharmacology, Regulatory, and CMC teams.Ensure biology data are... ...capability centers. Employees in remote-by-design or lab-based roles...Remote workRegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaImmediate startFlexible hours$186.23k - $279.35k
...Are you ready to steer global CMC strategy for cell and gene therapies that redefine what’s possible for patients... ...breakthrough programs, where your regulatory leadership translates pioneering... ...stages of product development and lead the development and implementation...RegulatoryHourly payTemporary work3 days per week- A biopharmaceutical company in Florida seeks a Compliance Officer to oversee regulatory affairs and compliance for gene therapy programs. This role ensures that the organization adheres to relevant laws and internal policies while guiding regulatory strategies. The ideal...Regulatory
$156k - $195k
...health, rare diseases, cell & gene therapies and CNS. With several... ...position of Senior Manager, Regulatory Affairs CMC (Oncology). The Senior Manager... ...a Regional Regulatory CMC Lead and supports the Global... ...Requirements: Primarily remote role with periodic on-site...Remote workRegulatoryFull timeWork at officeFlexible hours$244k - $305k
...oncology company developing novel targeted therapies for patients with RAS-addicted cancers.... ...for the role of Senior Director, Global CMC Lead. The Senior Director, Global CMC Lead... ...closely with CMC cross functional teams, Regulatory, Quality, Clinical Development, and external...RegulatoryFull timeLocal area- ...Alexion Pharmaceuticals, Inc. is seeking a Director, CMC Team Lead in New Haven, CT to guide CMC strategy across drug substance, drug product, analytics, quality, regulatory and clinical supply from Candidate Selection through First Approval. The role requires leading...Regulatory
- Northwestern Medicine is seeking a Senior Cellular Therapy Scientist to lead manufacturing of autologous and allogeneic cell and gene therapy products in a full-time daytime role. You will perform QC testing, ensure regulatory compliance, and maintain detailed processing...RegulatoryFull time
- ...pioneering biotech company is seeking a CMC Program Manager in Austin, Texas to lead cross-functional initiatives supporting groundbreaking therapies in women's health. This mid-senior... ...external partnerships, and ensuring regulatory compliance. Candidates should have a...Regulatory
- ## Director, CMC Team LeadNew Haven, Connecticut, United States of AmericaApply... ...with this jobAre you ready to lead the CMC strategy for high-potential therapies and turn scientific promise into... ...product, analytical, quality, regulatory, and clinical supply to deliver on...RegulatoryFlexible hours
$150k - $300k
...life sciences companies bring therapies to patients faster. As one... ...the General Manager, CMC, you will own all aspects of... ...directly to the Vice President of Regulatory, you will lead a high-performing team of... ...and/or stock bonus.#LI-Remote#LI-DirectorVeeva’s headquarters...Remote workRegulatoryWork at officeLocal areaWork from home3 days per week$190k - $240k
DescriptionLocation: Remote, Eastern Territory US Reporting to: Senior... ...Kirin company, is a global gene therapy leader focused on... ...serve as a team mentor, and lead national level initiatives. This... ...compliance with internal and external regulatory and legal guidelines.·...Remote workRegulatoryFull timeLocal area- ...science and bringing new therapies to patients worldwide.... ...As a Lead Clinical Research Associate... ...travel model, emphasizing remote oversight and overall study... ...Supports preparation of draft regulatory and ethics committee... ...types of Cell Therapy, Gene Therapy, or Nuclear Medicine...Remote workRegulatoryFull timeContract workWorldwideWork visa
$132k - $172k
...develop and deliver life-changing therapies to people living with rare... ...our vision of becoming a leading biopharmaceutical company... ...Summary:The Senior Manager, CMC Regulatory Affairs is responsible for providing... ...role is expected to be 100% remote.Total Rewards Offerings:...Remote workRegulatoryFull timeTemporary work$150k - $195k
...develop and deliver life-changing therapies to people living with rare... ...our vision of becoming a leading biopharmaceutical company... ...Summary:The Associate Director, CMC Regulatory Affairs is responsible for... ...role is expected to be 100% remote.Total Rewards Offerings:Travere...Remote workRegulatoryFull timeTemporary work
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Remote CMC Regulatory Lead - Gene Therapy. Be the first to apply!
- online remote Westborough, MA
- remote Westborough, MA
- remote medical data entry Westborough, MA
- part time recruiter remote Westborough, MA
- remote senior project manager Westborough, MA
- fully remote Westborough, MA
- remote database management Westborough, MA
- clinical data coordinator remote Westborough, MA
- remote finance internship Westborough, MA
- remote legal internship Westborough, MA

