Biotechnology Regulatory Lead

2 weeks ago


Alameda, California, United States Meet Life Sciences Full time
Global Regulatory Strategist Needed
Meet Life Sciences is a biotechnology company focused on developing innovative hematopoietic stem cell therapies to treat severe and life-threatening diseases. Our platform technology has the potential to cure over 70 diseases, providing patients with rapid and widespread access to consistent, durable, HLA-compatible, transgene-free blood stem cell therapies.
About the Position: As our new Vice President of Regulatory Affairs, you will be responsible for leading and overseeing all regulatory activities. Your key responsibilities will include developing and executing comprehensive global regulatory strategies, ensuring compliance with all applicable regulations, and facilitating the advancement of our innovative HSC therapies from development through approval and commercialization.
Main Responsibilities:
  • Develop and implement global regulatory strategies that align with business objectives and product development plans.
  • Manage the preparation, submission, and maintenance of regulatory filings, including INDs, NDAs, BLAs, CTAs, and MAAs, ensuring timely and successful approvals.
  • Act as the primary liaison with regulatory authorities, leading communications, negotiations, and meetings to facilitate product development and approval processes.
  • Maintain up-to-date knowledge of changes in regulations that may impact our products and operations, ensuring adherence to all relevant regulatory requirements and guidelines.
  • Collaborate with internal teams to provide regulatory guidance and support throughout the product lifecycle.
  • Build, mentor, and lead a high-performing regulatory affairs team, fostering a culture of excellence, collaboration, and continuous improvement.
  • Develop mitigation strategies to ensure successful product development and commercialization, identifying potential regulatory risks.


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