Regulatory Affairs Specialist
Há 5 horas
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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