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

Senior Regulatory Medical Writer - Pharma Submissions

Stealth Startup

Stealth Startup in San Francisco is seeking a Regulatory Medical Writer to prepare, review, and edit regulatory documents for FDA submissions, including INDs, NDAs, and BLA documents. You will ensure accuracy of clinical data, maintain compliance with FDA guidelines, and collaborate with clinical, regulatory, and scientific teams to craft submission-ready documents. Strong communication, meticulous project management, and timely delivery are essential. #J-18808-Ljbffr Stealth Startup

Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Senior Regulatory Medical Writer - Pharma Submissions in San Francisco, CA vacancy
  • Merck & Co., Inc. seeks an experienced Medical Writer to join the Nonclinical Pharmacology Documentation group. You will generate preclinical reports and regulatory submission modules, partnering with research and regulatory teams to ensure high-quality scientific and... 
    Senior
    Regulatory

    MSD Malaysia

    South San Francisco, CA
    3 days ago
  • Position Title: Senior Medical Content Writer Work Location: South San Francisco,...  ...hardest kind of writing in pharma: claims. You will develop,...  ...packages ready for MLR submission. Write medical content across...  ...with medical affairs and regulatory reviewers to resolve claim... 
    Senior
    Regulatory
    Work at office
    Monday to Friday

    Spectraforce Technologies

    South San Francisco, CA
    1 day ago
  • Merck & Co., Inc. in California seeks an experienced Medical Writer to join our Nonclinical Pharmacology Documentation group, managing multiple preclinical programs and regulatory modules. You will collaborate with research and regulatory teams to produce high-quality... 
    Senior
    Regulatory

    MSD

    South San Francisco, CA
    3 days ago
  • The Regulatory Medical Writer will play a critical role in the clinical development department, responsible for preparing, reviewing, and editing regulatory documents required for submission to the U.S. Food and Drug Administration (FDA) and other regulatory bodies. This... 
    Senior
    Regulatory
    Odd job

    Stealth Startup

    San Francisco, CA
    2 days ago
  •  ...~30 hours/week) to manage a variety of writing and editing projects, including Clinical Study Protocols, amendments, CSRs, regulatory submissions and DSUR responses. The role requires extensive experience in clinical/regulatory writing within biotech, strong communication... 
    Regulatory
    Remote job
    Contract work
    Part time
    For contractors

    Redbock - an NES Fircroft company

    San Francisco, CA
    3 days ago
  • Spectraforce Technologies is seeking a Senior Medical Content Writer in South San Francisco, CA. The role...  ..., and annotate claims for pharma content, working inside an in-house studio...  ...familiarity, and expertise in AMA style and regulatory guidelines. Strong collaboration with... 
    Senior
    Regulatory
    Work at office

    Spectraforce Technologies

    South San Francisco, CA
    1 day ago
  • Merck seeks an experienced Medical Writer to join the Nonclinical Pharmacology Documentation group. You will generate preclinical reports and submission modules, partner with research and regulatory functions, and manage multiple programs with competing timelines to meet... 
    Senior
    Regulatory

    Merck

    South San Francisco, CA
    2 days ago
  • YO AI Labs seeks an experienced Medical Writer Expert for remote contract work. You will develop, review, and evaluate clinical and regulatory documents with a focus on accuracy, regulatory compliance, and quality. This role requires deep expertise in CSRs, ICH guidelines... 
    Senior
    Regulatory
    Remote job
    Contract work

    YO AI Labs

    San Francisco, CA
    4 days ago
  • Veratherapeuticsinc seeks a Senior Manager, Regulatory CMC to manage regulatory submissions and activities within a dynamic team. This role requires strong regulatory...  ...bonuses, equity options, and comprehensive medical benefits. #J-18808-Ljbffr Veratherapeuticsinc
    Senior
    Regulatory

    Veratherapeuticsinc

    Brisbane, CA
    4 days ago
  • Pharmatech Associates, Inc. in San Francisco, CA seeks a senior Regulatory Affairs professional to lead development of regulatory strategies...  .... You will manage ANDA preparation, review, and submission processes, and serve as the primary contact with the US FDA,... 
    Senior
    Regulatory
    Remote job

    Pharmatech Associates, a USP company

    San Francisco, CA
    3 days ago
  • BridgeBio seeks a Senior Manager / Associate Director, CMC Regulatory Sciences in the San Francisco area for a hybrid role. The candidate will collaborate...  ...design control strategies, author and review regulatory submissions, and respond to health authority queries to support... 
    Senior
    Regulatory

    BridgeBio

    San Francisco, CA
    2 days ago
  • Penfield Search Partners Ltd is seeking a Senior Regulatory Submission Lead to drive a BLA submission across Module 2 and Module 5 for a Bay Area-based project. This 1-year contract role emphasizes hands-on submission execution, cross-functional coordination, and regulatory... 
    Senior
    Regulatory
    Contract work

    Penfield Search Partners Ltd

    San Francisco, CA
    4 days ago
  • $120 - $175 per hour

     ...penfieldsearch.comNo 3rd party candidatesLocation: Bay Area-based roleWork Model: 5 days onsite per weekWe are seeking a Senior Regulatory Submission Lead to support a critical BLA submission across Module 2 and Module 5. This 1 year contract role will provide hands-on... 
    Senior
    Regulatory
    Hourly pay
    Contract work

    Penfield Search Partners Ltd

    San Francisco, CA
    4 days ago
  • $265k - $285k

     ...CaliforniaCompany: Planet Pharma GroupContact:...  ...comResponsibilities include: Provides regulatory leadership in support...  ...Clinical Operations, Medical Affairs, CMC, and...  ...strategies and submissions, including CTAs, for new...  ...ability to influence senior leadership and cross-functional... 
    Senior
    Regulatory

    Planet Pharma

    Brisbane, CA
    8 hours ago
  • Marea Therapeutics seeks a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to lead regulatory strategies and submissions for the manufacturing of our products in the US and globally. The incumbent will oversee Regulatory CMC aspects of product... 
    Senior
    Regulatory

    BioSpace

    South San Francisco, CA
    2 days ago
  • The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) leads initiatives to develop and manage regulatory strategies for CMC submissions, including INDs/CTAs and amendments. This role builds relationships across Regulatory Affairs, Operations... 
    Senior
    Regulatory

    Allergan

    South San Francisco, CA
    4 days ago
  • Marea Therapeutics, based in South San Francisco, seeks a Senior Manager, Regulatory Affairs to lead regulatory planning and tactical...  ...coordinating with internal teams and external partners to drive submissions and regulatory strategy. The ideal candidate has >8 years... 
    Senior
    Regulatory

    BioSpace

    South San Francisco, CA
    3 days ago
  •  ...Senior Principal StatisticianA healthier future. It's what drives...  ...PDD, PD and the broader Roche Pharma organization.As trusted...  ...clinical pipeline and promote regulatory success — ultimately bringing...  ...decision-making and regulatory submissions.You are accountable for strategy... 
    Senior
    Regulatory
    Local area

    Genentech

    South San Francisco, CA
    4 days ago
  • $125k - $180k

     ...Development Scientist/Senior Clinical Development Scientist...  ...Science, and Regulatory to ensure high‑quality...  ...Participate in ongoing medical and scientific data review...  ...within biotech/pharma or equivalent academic...  ...involvement in  regulatory submissions (e.g., IND/CTA,... 
    Senior
    Regulatory
    Full time
    Interim role
    Local area
    Remote work

    Tenvie Therapeutics

    Brisbane, CA
    more than 2 months ago
  • $230k - $275k

    Senior Director, Commercial Manufacturing & CMC Development Eidos...  ...Therapeutics, an affiliate of BridgeBio Pharma, is a Phase 3 developmental-...  ...reliable product quality, regulatory compliance, and on-time...  ...sections for regulatory submissions, ensuring alignment with international... 
    Senior
    Regulatory
    Worldwide
    Flexible hours

    BridgeBio

    San Francisco, CA
    2 days ago
  •  ...The Position Senior Principal Statistician A healthier future...  ..., PD and the broader Roche Pharma organization. As trusted analytical...  ...pipeline and promote regulatory success - ultimately bringing...  ...-making and regulatory submissions. You are accountable for strategy... 
    Senior
    Regulatory
    Local area

    Genentech

    South San Francisco, CA
    3 days ago
  • Kite Pharma, a Santa Monica, CA-based biopharmaceutical company advancing CAR-T therapies, seeks a clinical trial professional to support...  ...start-up, execution, close-out, data analysis, reporting and regulatory filings. The role requires pharma or biopharma experience with... 
    Senior
    Regulatory

    Kite Pharma

    San Francisco, CA
    4 days ago
  • Denali Therapeutics Inc is seeking an experienced Regulatory Project Manager to drive the regulatory...  ...programs. You will partner with Regulatory Affairs, Medical Writing, Operations, and development SMEs to ensure submissions stay on track and aligned with program goals.... 
    Senior
    Regulatory

    Denali Therapeutics Inc

    South San Francisco, CA
    3 days ago
  • Kite Pharma, a leader in cancer immunotherapies, seeks a Director-level Submission Project Manager to drive regulatory submissions and cross-functional execution. You will align clinical data, regulatory strategy, and operations to ensure timely, high-quality filings across... 
    Regulatory

    Kite Pharma

    San Francisco, CA
    4 days ago
  • $136.9k - $254.2k

     ...PDD, PD and the broader Roche Pharma organization.As trusted...  ...clinical pipeline and promote regulatory success — ultimately bringing...  ...faster.The Opportunity: The Senior Statistician is a key member...  ...decision-making and regulatory submissions.You independently lead statistical... 
    Senior
    Regulatory
    Full time
    Local area

    Genentech

    South San Francisco, CA
    2 days ago
  • YO AI Labs is seeking an experienced Medical Writer / Clinical Document Author to develop and review regulatory documents with a focus on accuracy and compliance. The...  ...CSRs and related materials for regulatory submissions. You will verify data against source documents... 
    Regulatory
    Remote job

    YO AI Labs

    San Francisco, CA
    2 days ago
  • $136.9k - $254.2k

     ...PDD, PD and the broader Roche Pharma organization.As trusted...  ...clinical pipeline and promote regulatory success — ultimately bringing...  ...patients faster.The Opportunity:The Senior Biostatistician will work...  ...making and global regulatory submissions.Your Responsibilities:You drive... 
    Senior
    Regulatory
    Full time
    Local area

    Genentech

    South San Francisco, CA
    2 days ago
  • $250k - $286k

     ...Location: Brisbane, CaliforniaCompany: Planet Pharma GroupContact: ApplicationsEmail:...  ...Research/Pre-Clinical/CMC, Clinical and Regulatory documents in support of our programs.In...  ...and analytical skills.Build a scalable medical and scientific writing infrastructure, with... 
    Senior
    Regulatory
    Work at office
    Flexible hours

    Planet Pharma

    Brisbane, CA
    8 hours ago
  • $155k - $200k

     ...“Best Workplaces in Consulting and Professional Services”. Our Senior Consultants are our full-time employees and the competitive advantage...  ...clinical R&D through commercialization, including planning for regulatory, clinical, and commercial strategies and processes, and product... 
    Senior
    Regulatory
    Full time
    Work at office
    Work visa
    Relocation package
    Flexible hours

    Integrated Project Management

    San Francisco, CA
    4 days ago
  • $186k - $233k

     ...years in oncology trials. The role entails leading studies, collaborating with teams, and overseeing programming support for regulatory submissions in a dynamic environment. This opportunity offers competitive pay, from $186,000 to $233,000, depending on market... 
    Senior
    Regulatory

    REVOLUTION Medicines

    San Francisco, CA
    3 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Senior Regulatory Medical Writer - Pharma Submissions. Be the first to apply!