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
$175k - $195k
...Services is seeking an Associate Director of Regulatory Affairs in Berkeley, CA. This... ...and executing global CMC regulatory strategies for clinical-stage gene therapy programs. Ideal candidates have... ...regulatory experience, particularly in biotech, with strong communication and...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$221k - $286k
Overview Senior Director, Regulatory CMC - CAR T Cell Therapy provides global leadership and strategic direction for... ...and advisor to cross-functional leaders. The role partners closely with Technical... ...with cell therapy and/or gene therapy products; CAR‑T experience...SuggestedFor contractorsRemote workRelocationFlexible hours$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...SuggestedFull time$221k - $286k
Kite Pharma is seeking a Senior Director, Regulatory CMC - CAR T Cell Therapy to provide global leadership for CMC regulatory activities. This role will strategically guide CMC activities from development through commercialization of CAR T products. Located in California...Suggested$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...Full timeWork at officeRemote workFlexible hours- ...contributions can directly advance novel therapies for patients with cancer.... ...to the Senior Vice President, Regulatory Affairs, the Senior Director, Regulatory Affairs CMC will serve as the lead CMC... ...professional who thrives in a fast-paced biotech environment and enjoys owning...
- ...collaborate with cross-functional teams to drive innovation in cancer gene therapy programs. The ideal candidate will possess a PhD and/or MD... ...least 3 years of industry experience, excellent knowledge of regulatory processes, and hands-on experience with biomarker assays....
$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- The J David Gladstone Institutes in San Francisco is seeking a Scientific Program Leader to support projects at the Shipman Lab and the Gladstone Phage Therapy Center. This role includes managing scientific project communication, optimizing resource deployment, and identifying...
$195.5k - $272.5k
...encouraged to give their best. THE OPPORTUNITY Vir Biotechnology is seeking an 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$35 per hour
...Science & Clinical is seeking a Manufacturing Associate, Cell & Gene Therapy for a 6‑month contract position in the San Francisco Bay Area... ...documentation, equipment maintenance, and adherence to regulatory and quality standards. Perform additional responsibilities as...Contract work- ...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...
- GeneFab is seeking a Sr. Manager/Manager, Manufacturing to oversee cGMP operations in cell and gene therapy. The role requires a strong background in biologics and a proven leadership track record. This position will manage day-to-day manufacturing activities, ensuring...
- 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...
- ...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...
- Capricor Therapeutics, Inc. in Emeryville, California, is seeking an experienced facilities manager to oversee maintenance and operations in a biotechnology environment. This role involves ensuring compliance with GMP standards, managing a team, and collaborating on continuous...
- ...involves conducting CRISPR-based research aimed at developing therapies for inborn errors of immunity. Responsibilities include experimental... ...and hands-on experience with mammalian tissue culture and gene editing assays. This is a full-time exempt position offering full...Full time
- ...strategy for cutting‑edge biotech facilities that enable... ..., and advanced therapies. About HED We are a team... ...The Life Science Sector Leader is responsible for... ...Monitor industry trends and regulatory changes to ensure... ...emerging trends in cell and gene therapy, biologics...
- BridgeBio Pharma in California is seeking a Regulatory CMC professional to lead the regulatory strategy for IND, NDA, and MAA submissions. The role requires extensive experience in regulatory affairs within biotechnology and a strong ability to mentor team members. Responsibilities...Remote jobWork at office
$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- A leading biotech company in Alameda, California, is seeking an Assoc Scientific Regulatory Writing Director to lead the development of regulatory documents. This role requires extensive experience in the biotech/pharmaceutical industry and a strong understanding of regulatory...
$35 - $38.5 per hour
...Kelly® Science & Clinical is seeking Cell Therapy Manufacturing Associates for multiple 6-month contract... ...Minimum of 1 year of hands-on experience within a biotech or biopharma cGMP manufacturing environment; cell and gene therapy experience preferred. Strong working...Contract workShift work- Profluent Bio Inc. is seeking a Biotech Project Manager for Early Discovery in Emeryville, California. This role involves translating complex scientific initiatives into organized project plans while coordinating between science and management teams. You will oversee timelines...
$35 per hour
Kelly Science, Engineering, Technology & Telecom is seeking a Manufacturing Associate for a 6-month contract position in San Francisco. The role involves supporting laboratory and manufacturing operations while ensuring adherence to quality standards. Candidates should ...Contract work$148.5k - $209.5k
Assoc Scientific Regulatory Writing Director page is loaded## Assoc Scientific Regulatory Writing Directorlocations: Alameda, CAtime type: Full... ...preferred; BELS certification a plus.Experience:* Experience in Biotech/Pharmaceutical industry preferred.* Prior regulatory/...Contract workWork at officeLocal areaFlexible hours- The State Bar of California is seeking a Fiscal Supervisor for its Office of Access & Inclusion. This position is vital for overseeing financial management of grants to legal aid organizations, ensuring compliance, and fostering a team-oriented environment. The ideal candidate...Remote jobWork at office
$124.5k - $177k
Regulatory Affairs Strategy Manager (Oncology) page is loaded## Regulatory Affairs Strategy... ...regulatory agencies. Assists senior regulatory leaders with the development of documents to... .... After operating in the challenging biotech sector for 25 years, we have a proven track...For contractorsLocal areaFlexible hours- Precision Point is looking for a Director of Regulatory Affairs Strategy in San Francisco to lead the development and execution of global regulatory strategies across their clinical pipeline. This role involves managing cross functional teams and guiding regulatory strategy...
- ...conditions. They are among the world's leading biotech companies, with multiple products on the... .... Overview The Global Clinical Trial Leader (CTL) is accountable for the execution... ...of GCP/ICH requirements, international regulatory guidelines, and the end-to-end drug...Local areaFlexible hours
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