Regulatory Affairs Manager

hace 2 días

Xico, México Gilead Sciences A tiempo completo

About Gilead Sciences

Gilead Sciences is a leading biopharmaceutical company dedicated to creating a healthier world for all people. For over 35 years, we have been tackling some of the world's most pressing health challenges, including HIV, viral hepatitis, COVID-19, and cancer. Our mission requires collaboration, determination, and a relentless drive to make a difference.

Our Team

Every member of our team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions. We are looking for the next wave of passionate and ambitious individuals who are ready to make a direct impact.

People Leadership at Gilead

We believe every employee deserves a great leader. People Leaders are the cornerstone of the employee experience at Gilead and Kite. As a People Leader, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed, and empowered to fulfill their aspirations.

Job Summary

We are seeking a unique individual who is passionate about advancing therapeutics and has creative problem-solving skills to seamlessly meet business needs while maintaining regulatory compliance. This is an exciting opportunity for an experienced regulatory professional to join our Regulatory Affairs team, built on a strong sense of teamwork and excellence.

Responsibilities

  • Define, develop, and execute regulatory strategies to maximize regulatory success towards achievement of program objectives.
  • Provide strategic and tactical advice to achieve timely and efficient regulatory submissions (NDA and life cycle maintenance), while ensuring compliance with applicable regulatory requirements.
  • Engage with the broader Regulatory community within Gilead Sciences.
  • Contribute to cross-functional initiatives and represent the regulatory function at International project team meetings.
  • Collaborate cross-functionally to ensure the development and execution of robust regulatory strategies while ensuring regulatory compliance.
  • Ensure project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success while exercising sound judgment and communicating in a timely manner.
  • Anticipate and quantify risks and propose solutions, including the probability of success.
  • Accountable for regulatory submissions and approvals, in collaboration with internal and external stakeholders.
  • Participate in trade associations interactions/meetings.
  • Establish strong working relationships with the regulatory central team, other functions as required.

Requirements

This position is based in Mexico City and reports to the Sr Director of Regulatory Affairs. The ideal candidate will have a strong background in regulatory affairs and a passion for advancing therapeutics.

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