Current jobs related to Vice President Regulatory Affairs - San Jose, California - Meet Life Sciences


  • San Jose, California, United States Meet Life Sciences Full time

    Position : Vice President of Regulatory Affairs Location : San Francisco Bay Area (Also open to remote) About the Company : A biotechnology company pioneering the development of hematopoietic stem cell (HSC) therapies aimed at treating a broad spectrum of severe and life-threatening diseases. By generating self-renewing blood stem cells, this platform...


  • San Jose, California, United States PROCEPT BioRobotics Full time

    Vice President, Global Regulatory Affairs 2 days ago Be among the first 25 applicants This range is provided by PROCEPT BioRobotics. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range 261,524.00 / yr - $307,675.00 / yr Company Overview Embark on an enriching journey with PROCEPT...


  • San Jose, California, United States PROCEPT BioRobotics Full time

    Vice President, Global Regulatory Affairs2 days ago Be among the first 25 applicantsThis range is provided by PROCEPT BioRobotics. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.Base pay range261,524.00 / yr - $307,675.00 / yrCompany OverviewEmbark on an enriching journey with PROCEPT BioRobotics,...


  • San Jose, California, United States PROCEPT BioRobotics Full time

    Vice President, Global Regulatory Affairs2 days ago Be among the first 25 applicantsThis range is provided by PROCEPT BioRobotics. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.Base pay range261,524.00 / yr - $307,675.00 / yrCompany OverviewEmbark on an enriching journey with PROCEPT BioRobotics, where...


  • San Jose, California, United States PROCEPT BioRobotics Full time

    Vice President, Global Regulatory Affairs2 days ago Be among the first 25 applicantsThis range is provided by PROCEPT BioRobotics. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.Base pay range261,524.00 / yr - $307,675.00 / yrCompany OverviewEmbark on an enriching journey with PROCEPT BioRobotics, where...


  • San Mateo, California, United States Lensa Full time

    Vice President, Head of Global Patient AffairsVice President, Head of Global Patient Affairs1 day ago Be among the first 25 applicantsLensa is the leading career site for job seekers at every stage of their career. Our client, BeOne Medicines, is seeking professionals in San Mateo, CA. Apply via Lensa todayBeOne Medicines is seeking a transformational and...


  • San Francisco, California, United States Meet Life Sciences Full time

    Get AI-powered advice on this job and more exclusive features.Position Title: VP/SVP, Regulatory Affairs (FTE/permanent)Position SummarySeeking an experienced regulatory leader to establish and oversee global regulatory strategy for innovative cell therapies. This executive role will work closely with cross-functional teams to drive development, ensure...


  • San Francisco, California, United States 89bio Full time

    Join to apply for the Associate Director Regulatory Affairs role at 89bio Join to apply for the Associate Director Regulatory Affairs role at 89bio 89bio is a clinical-stage biopharmaceutical company dedicated to the development of best-in-class therapies for patients with liver and cardiometabolic diseases who lack optimal treatment options. The company is...


  • San Francisco, California, United States Lumicity Full time

    Location : Hybrid – San Francisco Bay Area (3 days onsite)Company OverviewOur client, a fast-growing digital health and SaMD startup, is developing AI-powered software that turns everyday devices into clinical-grade diagnostics. With several Class II devices in the pipeline, they're looking for a Vice President of Regulatory Affairs to lead global...


  • San Francisco, California, United States 89bio Full time

    Join to apply for the Associate Director Regulatory Affairs role at 89bio 1 week ago Be among the first 25 applicants Join to apply for the Associate Director Regulatory Affairs role at 89bio Get AI-powered advice on this job and more exclusive features. Direct message the job poster from 89bio 89bio is a clinical-stage biopharmaceutical company...

Vice President Regulatory Affairs

1 month ago


San Jose, California, United States Meet Life Sciences Full time

Position : Vice President of Regulatory Affairs

Location : San Francisco Bay Area (Also open to remote)

About the Company : A biotechnology company pioneering the development of hematopoietic stem cell (HSC) therapies aimed at treating a broad spectrum of severe and life-threatening diseases. By generating self-renewing blood stem cells, this platform technology aspires to provide patients with rapid and widespread access to consistent, durable, HLA-compatible, transgene-free blood stem cell therapies. This ground-breaking approach has the potential to cure more than 70 diseases, eliminating the reliance on donor or patient cells.

About the Role : The company is seeking an experienced and strategic Vice President of Regulatory Affairs to lead and oversee all regulatory activities. This executive will be responsible for developing and executing comprehensive global regulatory strategies, ensuring compliance with all applicable regulations, and facilitating the advancement of innovative HSC therapies from development through approval and commercialization. The VP of Regulatory Affairs will serve as the primary liaison with regulatory agencies and will provide strategic guidance to cross-functional teams to achieve regulatory objectives.

Responsibilities :

  1. Regulatory Strategy Development: Formulate and implement global regulatory strategies that align with business objectives and product development plans.
  2. Regulatory Submissions: Oversee the preparation, submission, and maintenance of regulatory filings, including INDs, NDAs, BLAs, CTAs, and MAAs, ensuring timely and successful approvals.
  3. Agency Interactions: Act as the primary point of contact with regulatory authorities, leading communications, negotiations, and meetings to facilitate product development and approval processes.
  4. Compliance Oversight: Ensure adherence to all relevant regulatory requirements and guidelines, maintaining up-to-date knowledge of changes in regulations that may impact the company's products and operations.
  5. Cross-Functional Collaboration: Work closely with internal teams, including R&D, Clinical, Quality, and Commercial, to provide regulatory guidance and support throughout the product lifecycle.
  6. Team Leadership: Build, mentor, and lead a high-performing regulatory affairs team, fostering a culture of excellence, collaboration, and continuous improvement.
  7. Risk Assessment: Identify potential regulatory risks and develop mitigation strategies to ensure successful product development and commercialization.

Qualifications :

  • Educational Background: Bachelor's degree in a scientific discipline is required; an advanced degree (Ph.D., PharmD, or equivalent) is preferred.
  • Experience: A minimum of 15 years of regulatory affairs experience in the biopharmaceutical industry, with a proven track record of securing regulatory approvals for innovative Cell therapy or Biologics products.
  • Expertise: In-depth knowledge of global regulatory requirements, including FDA, EMA, and ICH guidelines, with experience in managing complex regulatory projects.
  • Leadership Skills: Demonstrated ability to lead and develop high-performing teams, with excellent communication, negotiation, and interpersonal skills.
  • Strategic Thinking: Strong analytical and problem-solving abilities, with the capacity to develop and execute effective regulatory strategies that align with business goals.
  • Adaptability: Ability to navigate a dynamic and fast-paced environment, managing multiple projects and priorities effectively.

Pay range and compensation package: Pay range or salary or compensation

Equal Opportunity Statement: Include a statement on commitment to diversity and inclusivity.

#J-18808-Ljbffr