Regulatory Affairs Senior Manager
hace 3 semanas
Job Title: Regulatory Affairs Senior Manager
About the Role:
We are seeking a highly skilled Regulatory Affairs Senior Manager to join our team at Gilead Sciences. As a key member of our Regulatory Affairs team, you will be responsible for developing and executing regulatory strategies to ensure compliance with applicable regulatory requirements.
Key Responsibilities:
- Define, develop, and execute regulatory strategies to maximize regulatory success
- Provide strategic and tactical advice to achieve timely and efficient regulatory submissions
- Engage with the broader Regulatory community within Gilead Sciences
- Contribute to cross-functional initiatives and represent the regulatory function at International project team meetings
Essential Duties and Responsibilities:
- Collaborate cross-functionally to ensure the development and execution of robust regulatory strategies
- Ensure project team colleagues, line management, and key stakeholders are appraised of developments that may impact regulatory success
- Responsible for anticipating and quantifying risks and proposing solutions
- Accountable for regulatory submissions and approvals
Requirements:
- BSc, MSc, or PhD in a scientific discipline with extensive experience in the pharmaceutical/biotechnology industry in Mexico
- Extensive knowledge of the regulatory landscape in Mexico
- Experience in developing and implementing complex regulatory strategies
Gilead Core Values:
- Integrity (Doing What's Right)
- Inclusion (Encouraging Diversity)
- Teamwork (Working Together)
- Excellence (Being Your Best)
- Accountability (Taking Personal Responsibility)
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