Regulatory Affairs Specialist

Há 5 horas


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

We are seeking a highly skilled Regulatory Affairs Manager to join our team in Sao Paulo, Brazil. As a key member of our Regulatory Affairs team, you will be responsible for ensuring compliance with regulatory requirements and developing strategies to maximize regulatory success.

Key Responsibilities:

  • Support the definition and oversight of regulatory strategies to achieve program objectives
  • Provide strategic and tactical advice on regulatory submissions, including ATMP applications and life cycle maintenance
  • 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

Requirements:

  • BSc or MSc in a life sciences or related field with significant regulatory experience in the pharmaceutical/biotechnology industry in Brazil
  • Experience in cell therapy will be an advantage
  • Extensive knowledge of regulatory requirements in biologicals and in managing close interactions with HA
  • Excellent verbal and written English communication skills, including relevant technical/ATMP language skills

About Us:

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. We are committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer.



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