CMC Regulatory Director - Gene Therapy, Biotech Leader
$200k - $235kEvolving Solution Services
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 affairs, specifically in biotech, with at least 10-12 years of experience. A competitive salary is offered between $200,000 and $235,000 annually, along with performance bonuses and equity awards. #J-18808-Ljbffr Evolving Solution Services
$285k - $320k
...In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising... ...quality of work. What You'll Do Lead CMC regulatory strategy and execution across development... ...Expanded mental health support (therapy and coaching resources) Hybrid work model...SuggestedWork at officeRemote workFlexible hours$200k - $235k
...Therapeutics, Inc. is searching for a Director of Regulatory Affairs CMC, responsible for developing and... ...regulatory strategies for clinical-stage gene therapy programs. This senior position... ...regulatory experience, preferably in biotech/pharma and gene therapy. The role...Suggested$200k - $235k
...alternative application process. Director, Regulatory Affairs Full Time... ...in-class vision restoration therapies for people with degenerative... ...who thrives in a fast-paced biotech environment and can operate... ...functional teams (clinical, CMC, nonclinical, quality) to ensure...SuggestedFull time$240k - $275k
...Position Summary The Director, Clinical Regulatory Affairs serves as a senior regulatory leader responsible for shaping... ..., Safety, and CMC leadership and serves... ...affairs experience in biotech/pharma, with substantial... ...Experience with biologics, gene therapies, cell therapies, or...SuggestedLocal area- Vir Biotechnology, Inc. is seeking a highly motivated Director of Regulatory CMC to lead global regulatory strategy for clinical development and commercialization across multiple modalities. You will collaborate with Technical Operations and Regulatory Affairs to plan...SuggestedWork at office3 days per week
$170k - $185k
...Job/Role Title: Senior Manager, Regulatory Affairs Reporting to: Chief Regulatory Officer... ...developing best-in-class vision restoration therapies for people with degenerative retinal... ...programs, collaborating closely with Clinical, CMC, Nonclinical, and Quality teams Manage...Work at office2 days per week$200k - $235k
...an alternative application process. Director, Regulatory Affairs - CMC Full Time Professional Berkeley, CA... ...strategies for clinical-stage gene therapy programs. This individual will partner... ...of regulatory affairs experience in biotech/pharma. Experience supporting biologics...Full time$230k - $270k
...biopharmaceutical company developing novel therapies with the potential to... ...Reporting to the Vice President of Regulatory Affairs, the Director of Regulatory Affairs CMC will serve as a key member of... ...regulatory affairs experience in biotech/pharma Preferred Skills...- ...Executive Director, Regulatory Affairs About the Company Esteemed company... ...Specialties cell therapy autoimmune and lupus... ...requires a seasoned regulatory leader with deep experience in... .... Experience in cell and/or gene therapy, particularly in the...
$186k - $233k
...oncology company developing novel targeted therapies for patients with RAS‑addicted... ...seek a strategic and hands‑on Associate Director, CMC Regulatory who will be responsible for executing... ...field. 10+ years of pharmaceutical / biotech drug development experience with 5+...Work experience placement- Kennedy Bond is seeking an Executive Director, Global Medical Expert to support upcoming gene therapy launches. This remote role will involve collaboration with treatment centers and cross-functional teams to ensure successful execution of therapies. The ideal candidate...Remote job
- ...manufacturing operations, focusing on building and leading a high-performing team, and ensuring the delivery of quality cell and gene therapy products. The ideal candidate will have at least 6 years of experience in a regulated industry, strong leadership skills, and...
$211k - $264k
...company developing novel targeted therapies for patients with RAS-... ...pathway. The Opportunity The Director of Regulatory Affairs (Global Filing Lead)... ..., Clinical, Biostatistics, CMC, Quality, Translational... ...years in the pharmaceutical/biotech industry or relevant work experience...Full timeWork experience placementLocal area- BridgeBio Pharma is seeking an Associate Director of KOL Management to lead collaborations... ...for Infigratinib, the first oral therapy for achondroplasia. This US-based remote... ...extensive interaction with key opinion leaders and requires strong clinical acumen and...Remote work
$195.5k - $272.5k
...encouraged to give their best. THE OPPORTUNITY Vir Biotechnology is seeking a highly motivated, self‑driven and enthusiastic Director of Regulatory CMC accountable for ensuring all assigned products have a successful regulatory CMC strategy for clinical development and...Full timeWork at officeWork visa3 days per week$170k - $185k
A biotechnology company focused on vision restoration therapies seeks a Senior Manager, Regulatory Affairs in Berkeley, CA. This role involves developing regulatory strategies for clinical-stage programs and managing interactions with agencies like the FDA. The ideal candidate...$285k - $320k
BridgeBio is hiring for a CMC Regulatory Lead in San Francisco, responsible for leading regulatory strategies for drug approvals and submissions... ...extensive experience in Regulatory Affairs CMC within the biotech or pharmaceutical industry and be adept at managing complex...Remote job$244k - $305k
...company developing novel targeted therapies for patients with RAS‑addicted... ...collaborative, and execution‑oriented leader for the role of Senior Director, Global CMC Lead. The Senior Director, Global... ...with CMC cross‑functional teams, Regulatory, Quality, Clinical Development,...Full timeLocal area- ...division. As part of this growth, the organization is seeking a Regulatory Affairs Manager CMC to join their Regulatory team in San Francisco. This is... ..., CMC, and quality. The role will report directly to the Director of Regulatory Affairs and contribute to advancing...
- A growing biotechnology company in San Francisco is seeking a Senior Director, Regulatory Affairs to lead their global regulatory strategy and oversee submission activities. The position requires over 10 years of regulatory affairs experience, including 5 years at the...
- Revolution Medicines in San Francisco is looking for an Associate Director, CMC Regulatory to lead the execution of regulatory strategies for clinical development and lifecycle management of pipeline products. This strategic position will involve collaboration with various...
$131.2k - $344.4k
...Pediatric Sarcoma Leader UCSF School of Medicine and UCSF Benioff Children's Hospitals Division of Oncology, Department of Pediatrics... .../translational research who will help advance innovative therapies and expand clinical trial opportunities for children and young...- Kyverna Therapeutics, Inc. is seeking a Director of Program Management in Emeryville, CA. This crucial role involves leading cross-functional teams to advance innovative engineered T cell therapies. The director will manage complex programs, ensuring effective communication...
- ...develop procurement strategies that optimize sourcing and build strong supplier partnerships, enhancing the supply chain for cancer therapies. The ideal candidate will have a bachelor's degree in Supply Chain and extensive experience in the life sciences sector. This role...
- Corvus Pharmaceutical in San Francisco, CA, seeks a Director of Regulatory Affairs CMC to lead global CMC regulatory strategies for clinical-stage... ...timely, compliant submissions. The role demands 10+ years in biotech/pharma regulatory affairs, with strong experience in...
- A well-established global pharmaceutical company is seeking a Regulatory Affairs Manager CMC for its San Francisco team. This role involves developing CMC regulatory strategies and managing submissions like INDs and NDAs, ensuring compliance with regulatory authorities...
- ...is seeking a senior patent attorney to lead its intellectual property strategy, focusing on complex patent portfolios for cancer therapies. The ideal candidate will have over 10 years of experience in patent prosecution and will work closely with senior leadership to manage...
- ...of our R&D team. This position focuses on the design and interpretation of non‑clinical DMPK data, crucial for the progression of therapies through clinical studies. The ideal candidate will have a PhD and over 5 years of bio/pharmaceutical industry experience. We offer...
$210k - $235k
...developing best-in-class therapies that address critical... .... Role Overview The Director, Clinical Compliance... ...Jade adhere to ICH-GCP, regulatory requirements, internal... ...GCP compliance leader who partners closely with... ...relevant experience in biotech/pharma or CRO roles in...Remote work$244k - $305k
Revolution Medicines is seeking a Senior Director, Global CMC Lead to provide cross-functional leadership and drive integrated CMC strategies... ...will have extensive experience in CMC activities and regulatory submissions. This role involves collaborating with R&D and...
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