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

Senior Regulatory PM Lead for IND/CTA to NDA

Denali Therapeutics

Denali Therapeutics is seeking an Associate Director, Regulatory Project Manager in South San Francisco to drive regulatory timelines, coordinate cross-functional teams, and manage risk across IND/CTA-to-BLA/NDA pathways. The role requires senior PM experience, ability to influence stakeholders, and mentoring of junior staff within Regulatory Affairs. Denali offers a competitive compensation package and comprehensive benefits. #J-18808-Ljbffr Denali Therapeutics

Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Senior Regulatory PM Lead for IND/CTA to NDA in South San Francisco, CA vacancy
  • Nurix Therapeutics in Brisbane, CA is seeking a Senior Clinical Trial Associate (Sr. CTA) to own TMF integrity, coordinate CRO activities, and guide...  ...functional teams, support training materials, and help ensure regulatory readiness across studies while #J-18808-Ljbffr RiseMe
    Senior
    Regulatory

    RiseMe

    Brisbane, CA
    1 day ago
  •  ...development programs, with collaboration across research and regulatory functions. The successful candidate will manage multiple programs...  ..., and ensure high-quality regulatory documents for CTD, IND, NDA/BLA/MAA submissions, while contributing to templates and adopting... 
    Senior
    Regulatory

    Merck & Co. Inc

    South San Francisco, CA
    2 days ago
  • $261k - $304.5k

    ## Senior Director, CMC Lead Product DevelopmentApplylocations: South San Francisco, Californiatime...  ...supply chain, CMC, quality, regulatory, program & portfolio management.This...  ...experiences of leading a CMC team through IND and NDA/MAA preferred. + Must possess good scientific... 
    Senior
    Regulatory

    Cytokinetics

    South San Francisco, CA
    1 day ago
  • Vice President / Senior Vice President, Global Development Leader...  ...for safety and compliance with regulatory requirements and standard...  ...this leader are listed below. Lead one or more Program teams comprised...  ...and activities, such as IND’s and NDA/MAAs Interact with principal... 
    Senior
    Regulatory
    Contract work

    Initial Therapeutics, Inc.

    Brisbane, CA
    3 days ago
  •  ...invites you to contribute to our large molecule pipeline by leading purification/downstream process characterization and...  ..., coordinate studies, review results, and draft IND/BLA sections to support regulatory filings. Ideal candidates hold a PhD in Biology/ Biochemistry... 
    Regulatory

    Denali Therapeutics Inc

    South San Francisco, CA
    5 days ago
  • Roche Genentech in Holly Springs, NC, seeks a Senior Quality Compliance Specialist to lead QRM, data integrity, and regulatory compliance initiatives within a fast-paced, high-tech manufacturing environment. You will collaborate with Engineering, MSAT, Operations, Quality... 
    Senior
    Regulatory

    Roche

    South San Francisco, CA
    4 days ago
  • Structure Therapeutics Inc. is seeking an Associate Director of Medical Writing to lead the development of regulatory and clinical documents for its drug programs. You will oversee authoring, reviewing, and finalizing pivotal documents and ensure compliance with FDA, EMA... 
    Senior
    Regulatory
    Remote job

    Structure Therapeutics Inc.

    South San Francisco, CA
    3 days ago
  • Scorpion Therapeutics in South San Francisco is seeking a Senior Clinical Data Manager Lead to guide data collection, standardization, and quality...  ...ensuring compliance with ICH/FDA, CDISC standards, and regulatory expectations. This role requires strategic problem-solving... 
    Senior
    Regulatory

    Scorpion Therapeutics

    South San Francisco, CA
    1 day ago
  • Cytokinetics is seeking a Sr. Manager Regulatory Operations - Systems to support operational management and continuous improvement of Regulatory Information Management systems, with a focus on Veeva Vault RIM, based in South San Francisco, CA. The role involves supporting... 
    Senior
    Regulatory

    Cytokinetics (Ireland) Limited

    South San Francisco, CA
    4 days ago
  • Neurona Therapeutics is seeking an Associate Director, Recruiting to lead hands-on talent acquisition across R&D, clinical operations, regulatory, quality, manufacturing and corporate functions in a fast-moving cell therapy environment. You will partner with hiring managers... 
    Senior
    Regulatory

    Socket

    South San Francisco, CA
    1 day ago
  •  ...Associate Director of Medical Communications and Publications to lead strategic publication planning and publication execution across...  ...teams (biostatistics, clinical development, medical affairs, regulatory) and manage external agencies, vendors, and #J-18808-Ljbffr Rigel... 
    Senior
    Regulatory

    Rigel Pharmaceutical

    South San Francisco, CA
    2 days ago
  •  ...-functional teams to ensure scientific rigor and data integrity across studies. The successful candidate will lead SAP development, support protocols and regulatory submissions, and advise on study design and adaptive methodologies. #J-18808-Ljbffr Aligos Therapeutics
    Senior
    Regulatory
    For contractors

    Aligos Therapeutics

    South San Francisco, CA
    2 days ago
  • Structure Therapeutics Inc. is seeking an Associate Director of Medical Writing to lead regulatory and clinical document development, ensure regulatory compliance, and manage multiple projects in a fast-paced environment. You will provide strategic guidance on writing templates... 
    Senior
    Regulatory

    structuretx

    South San Francisco, CA
    2 days ago
  • Genentech, a Roche subsidiary in South San Francisco/Boston, seeks a Senior Statistician to lead statistical input into trial design, develop analysis plans, and support regulatory submissions. You will design and interpret analyses, mentor junior staff, and collaborate... 
    Senior
    Regulatory

    Genentech

    South San Francisco, CA
    1 day ago
  • Veracyte, Inc. is seeking a Principal Bioinformatics Scientist to lead MRD assay bioinformatics, from concept to analytical validation...  ...strategy, partner with wet-lab and clinical teams, and drive regulatory-compliant development of LDTs for oncology indications. You... 
    Senior
    Regulatory

    Veracyte

    South San Francisco, CA
    2 days ago
  • $299k - $349k

     ...global biopharmaceutical company in California is seeking a Senior Medical Director to lead late-stage clinical development programs in Oncology....  ...and collaboration with cross-functional teams to ensure regulatory compliance. The pay range is between $299K and $349K per... 
    Senior
    Regulatory

    Zai Lab

    South San Francisco, CA
    2 days ago
  •  ...translate nonclinical data into human PK and dose predictions. The role requires a PhD in pharmacokinetics or related field, 2+ years of DMPK project leadership, and strong communication skills to inform senior stakeholders and regulatory discussions. #J-18808-Ljbffr Roche
    Senior
    Regulatory

    Roche

    South San Francisco, CA
    2 days ago
  •  ...Onsite four days a week at South San Francisco or San Diego offices. You will lead monitoring oversight plans, assess reports, and guide clinical ops teams to mitigate risks and ensure regulatory compliance. Strong analytical and communication skills are essential. #J-18... 
    Senior
    Regulatory

    BioSpace

    South San Francisco, CA
    1 day ago
  •  ...interpretation of clinical trial data, reporting to Head of Biostatistics, collaborating with cross-functional teams to ensure rigor and regulatory readiness. Ideal candidate holds a Master’s or PhD in Biostatistics or related field, 3+ years in late-stage trial design, 4-6... 
    Senior
    Regulatory
    Remote job
    Contract work
    Temporary work
    Part time

    Aligos Therapeutics, Inc.

    South San Francisco, CA
    5 days ago
  • A biotech research company in South San Francisco seeks an Associate Director of Medical Writing to lead the development of high-quality clinical and regulatory documents. The ideal candidate must possess a Master's degree and over 8 years of experience in scientific writing... 
    Senior
    Regulatory

    Calico Life Sciences

    South San Francisco, CA
    2 days ago
  • Nurix Therapeutics is seeking a Senior Director, Quality Control to establish and lead a QC organization supporting programs from CMC development through commercial manufacturing. The role requires regulatory acumen and experience managing external CDMOs and CTLs to ensure... 
    Senior
    Regulatory

    Initial Therapeutics, Inc.

    Brisbane, CA
    3 days ago
  •  ...providers, and coordinate cross‑functional activities to ensure timely, on‑budget delivery of late‑stage studies. The SCTM collaborates with teams in the US and Shanghai, supports regulatory readiness, and ensures SOP compliance. #J-18808-Ljbffr Structure Therapeutics
    Senior
    Regulatory

    Structure Therapeutics

    South San Francisco, CA
    5 days ago
  •  ...Product Safety Team (PST) lead for late stage oncology...  ...architects, safety PM, and other cross functional...  ...PK and toxicology leads, regulatory and clinical development...  ...safety components of pre-NDA and NDA/sNDA submissions...  ...regulatory submissions (IND/BLA submissions) is... 
    Senior
    Regulatory

    PowerToFly

    South San Francisco, CA
    2 days ago
  • Kardigan seeks a Senior Director, CMC Regulatory to lead the development and execution of CMC regulatory strategies driving global submissions and...  ...affairs, strong FDA/EMA/ICH knowledge, and experience with IND/IMPD and NDA/MAA submissions, preferably in small molecules. #J-1... 
    Senior
    Regulatory

    Kardigan

    South San Francisco, CA
    4 days ago
  • $258k - $320k

     ...experienced team has secured partnerships with leading global biopharmaceutical companies,...  ...Responsible for leading the global CMC regulatory strategy and execution for both small...  ...molecules and biologics, including IND/ CTA , NDA/BLA/ MAA applications. Oversee the end-... 
    Senior
    Regulatory
    Work at office
    Worldwide
    Relocation package

    Zai-Lab-

    South San Francisco, CA
    3 days ago
  •  ...an NES Fircroft company seeks a Drug Development Program Manager to support early-stage IND/CTA preparation and late-stage regulatory submissions, partnering with Global Program Leads and cross-functional teams to drive Integrated Development Plans (IDPs) across the... 
    Senior
    Regulatory

    Redbock - an NES Fircroft company

    Brisbane, CA
    5 days ago
  • $224k - $299k

     ...seeking a Director (or Senior Director) of Translational...  ...patients' lives by leading translational medicine...  ...medicine function, from IND/CTA through clinical proof-...  ...strategy, GCP adherence, and regulatory-authority interactions,...  ...proof-of-concept to NDA/BLA submission AI/ML... 
    Senior
    Regulatory
    Work at office
    Home office
    Flexible hours
    3 days per week

    insitro

    South San Francisco, CA
    5 days ago
  • A leading staffing solutions firm is seeking a Sr. Veeva Business Analyst in South San Francisco, CA. The ideal candidate will have over 5 years of experience in the pharmaceutical or medical devices industry, along with at least 4 years of Veeva CRM administration expertise... 
    Senior

    360 IT Professionals

    South San Francisco, CA
    5 days ago
  • $131.4k - $206.8k

     ...applications. This individual will partner with various research and regulatory functions to prepare high-quality scientific and regulatory...  ...filings for nonclinical modules in the context of CTD, IND, CTA, IMPD, NDA/BLA/MAA. Excellent scientific writing and editing skills... 
    Senior
    Regulatory
    For contractors
    Work at office
    Local area
    Relocation
    Visa sponsorship
    Flexible hours
    Shift work

    Merck & Co.

    South San Francisco, CA
    2 days ago
  • $248k - $310k

     ...preventable, curable and no longer the leading cause of death in the world. It is...  ..., every day. Position Title: Senior Director, CMC Regulatory Department: Regulatory Affairs Reports...  ...early and late phase submissions (IND/IMPD and NDA/MAA, amendments, and annual reports... 
    Senior
    Regulatory

    Kardigan, Inc.

    South San Francisco, CA
    2 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Senior Regulatory PM Lead for IND/CTA to NDA. Be the first to apply!