Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

CMC Regulatory Director - Gene Therapy, Biotech Leader

$200k - $235k

Evolving 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

Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the CMC Regulatory Director - Gene Therapy, Biotech Leader in Berkeley, CA vacancy
  • $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

    Evolving Solution Services

    Berkeley, CA
    2 days ago
  • $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... 
    Suggested
    Full time

    Evolving Solution Services

    Berkeley, CA
    3 days ago
  • $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... 
    Suggested
    For contractors
    Remote work
    Relocation
    Flexible hours

    Kite Pharma

    San Francisco, CA
    10 hours ago
  • $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... 
    Suggested
    Full time

    Evolving Solution Services

    Berkeley, CA
    1 day ago
  • $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

    Kite Pharma

    San Francisco, CA
    3 days ago
  • $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 time
    Work at office
    Remote work
    Flexible hours

    BridgeBio

    San Francisco, CA
    4 days ago
  •  ...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... 

    Kaye/Bassman International

    San Francisco, CA
    2 days ago
  •  ...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.... 

    Pattern Biosciences

    Emeryville, CA
    3 days ago
  • $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

    BridgeBio

    San Francisco, CA
    3 days ago
  • 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... 

    The J David Gladstone Institutes

    San Francisco, CA
    4 days ago
  • $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 time
    Work at office
    Work visa
    3 days per week

    Vir Biotechnology

    San Francisco, CA
    3 hours ago
  • $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

    Kelly Science, Engineering, Technology & Telecom

    San Francisco, CA
    2 days ago
  •  ...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... 

    Barrington James

    San Francisco, CA
    3 days ago
  • 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... 

    GeneFab

    Alameda, CA
    10 hours ago
  • 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... 

    Barrington James

    San Francisco, CA
    2 days ago
  •  ...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... 

    Scientific Search

    Emeryville, CA
    3 days ago
  • 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...

    Capricor Therapeutics, Inc.

    Emeryville, CA
    2 days ago
  •  ...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

    Inside Higher Ed

    Berkeley, CA
    2 days ago
  •  ...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... 

    Harley Ellis Devereaux (HED)

    San Francisco, CA
    2 days ago
  • 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 job
    Work at office

    BridgeBio Pharma

    San Francisco, CA
    4 days ago
  • $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

    Jade Biosciences

    San Francisco, CA
    3 days ago
  • 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... 

    Exelixis, Inc.

    Alameda, CA
    2 days ago
  • $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 work
    Shift work

    Kelly

    Alameda, CA
    1 day ago
  • 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... 

    Profluent Bio Inc.

    Emeryville, CA
    1 day ago
  • $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

    Kelly Science, Engineering, Technology & Telecom

    San Francisco, CA
    2 days ago
  • $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 work
    Work at office
    Local area
    Flexible hours

    Exelixis, Inc.

    Alameda, CA
    2 days ago
  • 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 job
    Work at office

    State Bar of California

    San Francisco, CA
    2 days ago
  • $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 contractors
    Local area
    Flexible hours

    Exelixis, Inc.

    Alameda, CA
    1 day ago
  • 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... 

    Precision Point

    San Francisco, CA
    2 days ago
  •  ...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 area
    Flexible hours

    Compass Consulting

    San Francisco, CA
    5 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to CMC Regulatory Director - Gene Therapy, Biotech Leader. Be the first to apply!