Regulatory Affairs Specialist

2 semanas atrás


São Paulo, São Paulo, Brasil Gilead Sciences, Inc. Tempo inteiro
Regulatory Affairs Manager

Gilead Sciences, Inc. is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our regulatory affairs group, you will be responsible for ensuring compliance with regulatory requirements and guidelines for our cell therapy products.

Key Responsibilities:

  • Develop and implement regulatory strategies to support the development and commercialization of cell therapy products
  • Collaborate with cross-functional teams to ensure regulatory compliance and quality
  • Prepare and submit regulatory documents, including INDs, NDAs, and MAAs
  • Provide regulatory guidance and support to internal stakeholders

Requirements:

  • Advanced degree in a life science or related field
  • Minimum 5 years of experience in regulatory affairs, preferably in the biotechnology or pharmaceutical industry
  • Strong knowledge of regulatory requirements and guidelines for cell therapy products
  • Excellent communication and project management skills

What We Offer:

  • Opportunity to work on cutting-edge cell therapy products
  • Collaborative and dynamic work environment
  • Competitive salary and benefits package


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