Regulatory Affairs Senior Manager

hace 3 semanas


Ciudad de México, Ciudad de México Gilead Sciences A tiempo completo

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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