Regulatory Affairs Specialist

Há 3 dias


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

At Gilead Sciences, we're committed to creating a healthier world for all people. As a Regulatory Affairs Manager, you'll play a critical role in ensuring the development and execution of robust regulatory strategies that meet the business needs while maintaining regulatory compliance.

Key Responsibilities:
  • Support the definition, setting, and oversight of regulatory strategies to maximize regulatory success towards achievement of program objectives.
  • Provide strategic and tactical advice to achieve timely and efficient regulatory submissions, including Advanced Therapy Medicinal Products (ATMP) applications and life cycle maintenance submissions.
  • Lead regulatory submissions for new ATMP applications and life cycle maintenance.
  • Engage with the broader Regulatory community within Gilead.
  • Contribute to cross-functional initiatives representing the regulatory function and interacting with a diverse number of stakeholders both internal and externally.
Requirements:
  • BSc or MSc in a life sciences or related field with significant regulatory experience (minimum 6 years) in the pharmaceutical/biotechnology industry in Brazil.
  • Experience in cell therapy will be an advantage.
  • Extensive knowledge of regulatory requirements in biologicals (highly desirable in the field of cell therapy) and in managing close interactions with HA.
  • Experience in developing complex regulatory strategies and leading regulatory submissions.
What We Offer:
  • Opportunity to work in a dynamic and collaborative environment.
  • Chance to contribute to the development of life-changing scientific innovations.
  • Competitive salary and benefits package.


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