Regulatory Affairs Specialist
4 semanas atrás
Job Description
Gilead Sciences is seeking a highly skilled Regulatory Affairs professional to join our team in Sao Paulo. As a Regulatory Affairs Specialist, you will play a critical role in ensuring the development and execution of robust regulatory strategies while maintaining regulatory compliance.
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.
- 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.
Gilead Core Values:
- Integrity (Doing What's Right)
- Inclusion (Encouraging Diversity)
- Teamwork (Working Together)
- Excellence (Being Your Best)
- Accountability (Taking Personal Responsibility)
Leadership Commitments:
- I AM BOLD in aspiration and AGILE in execution.
- I CARE and make time for people.
- I LISTEN, speak openly, and explain the 'why.'
- I TRUST others and myself to make sound decisions.
- I OWN the impact of my words and actions.
Equal Employment Opportunity:
Gilead Sciences Inc. is an equal opportunity employer committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information, or other non-job-related characteristics.
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