Regulatory Affairs Specialist
Há 3 dias
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for over three decades. We are committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer.
Job SummaryWe are seeking a highly skilled Regulatory Affairs Manager to join our team in Sao Paulo, Brazil. The successful candidate will be responsible for developing and executing robust regulatory strategies to ensure compliance with applicable regulations and internal policies.
Key Responsibilities- Support the definition, setting, and oversight of regulatory strategies to maximize regulatory success.
- 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.
- 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.
Gilead Sciences, Inc. offers a dynamic and challenging work environment, with opportunities for professional growth and development. We are committed to creating a healthier world for all people and are seeking talented individuals who share our vision.
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