Regulatory Affairs Senior Manager

hace 6 días

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

Job Overview

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this position.

At Gilead, we are dedicated to fostering a healthier world for everyone. For over 35 years, we have addressed critical health issues such as HIV, viral hepatitis, COVID-19, and cancer, tirelessly working to develop therapies that enhance lives and ensure global access to these treatments. Our ongoing battle against significant health challenges demands collaboration, determination, and an unwavering commitment to making a difference.

Every member of Gilead's workforce plays a vital role in the discovery and development of transformative scientific innovations. Our employees are our most valuable asset as we strive to achieve our ambitious goals, and we seek the next generation of passionate and driven individuals ready to make a tangible impact.

We believe that every employee deserves exceptional leadership. People Leaders are fundamental to the employee experience at Gilead and Kite. As a people leader now or in the future, you will be instrumental in evolving our culture and fostering an environment where every employee feels included, developed, and empowered to realize their aspirations. Join Gilead and help create possibilities together.

Position Summary

We are in search of a distinctive individual who is enthusiastic about advancing therapeutics and possesses innovative problem-solving abilities to effectively address business needs while ensuring regulatory compliance.

This is an exciting opportunity for a seasoned regulatory professional to become part of the Regulatory Affairs team, which is founded on a strong sense of teamwork and excellence. The role entails close collaboration with a diverse array of stakeholders, both internally and externally.

  • Formulate, develop, and implement regulatory strategies to optimize regulatory success in achieving program objectives.
  • Provide strategic and tactical guidance to ensure timely and efficient regulatory submissions, including NDA and lifecycle management, while adhering to applicable regulatory standards.
  • Engage with the broader regulatory community within Gilead Sciences.
  • Contribute to cross-functional initiatives and represent the regulatory function in international project team meetings.

Key Responsibilities:

  • Collaborate across functions to ensure the development and execution of comprehensive regulatory strategies while maintaining compliance.
  • Keep project team members, management, and key stakeholders informed of developments that may affect regulatory success, exercising sound judgment and timely communication.
  • Anticipate and assess risks, proposing solutions that include the likelihood of success.
  • Oversee regulatory submissions and approvals in partnership with internal and external stakeholders.
  • Participate in interactions and meetings with trade associations.
  • Establish strong working relationships with the regulatory central team and other necessary functions.
  • Engage in or lead departmental and cross-functional task forces and initiatives.
  • Monitor and anticipate trends that influence the regulatory landscape and adjust regulatory strategies accordingly.
  • Facilitate the registration of manufacturing sites in compliance with national requirements.
  • Serve as the primary contact at cross-functional and international project team meetings.
  • Review and approve promotional materials in accordance with national regulations and company policies.
  • Support the maintenance of GDP, Importer's and Wholesaler's licenses, and Quality Agreements related to cell/gene therapy products.
  • Demonstrate Gilead's leadership commitments.

Qualifications:

  • BSc, MSc, or PhD in a scientific discipline with extensive experience in the pharmaceutical or biotechnology industry.
  • In-depth knowledge of the regulatory landscape.
  • Experience in developing and executing complex regulatory strategies.
  • Proficient in critically reviewing intricate technical documents and influencing colleagues across functions for successful regulatory strategy implementation.

Skills & Attributes:

  • Self-motivated, enthusiastic, resilient, and energizing.
  • Proactive in sharing knowledge and educating colleagues across the organization.
  • Able to adapt in a dynamic environment.
  • Resilient with the capability to influence and deliver results in ambiguous situations.
  • Skilled in engaging and managing multiple stakeholders to achieve objectives.
  • Capable of transitioning from strategic to operational to meet established plans and business needs.
  • Excellent verbal and written communication skills, with strong negotiation and interpersonal abilities.
  • Detail-oriented and a collaborative team player.

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.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this position.

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