Regulatory Affairs Manager

hace 4 semanas

Ciudad de México, Ciudad de México Gilead Sciences Mexico, S. de R.L. de C.V. A tiempo completo

Description



At Gilead Sciences Mexico, S. de R.L. de C.V., we are seeking a talented Regulatory Affairs professional to join our Regulatory Affairs team. This is a unique opportunity to work on advancing therapeutics while ensuring regulatory compliance.



This role involves close collaboration with various stakeholders to define, develop, and execute regulatory strategies that maximize regulatory success. The ideal candidate will have extensive experience in the pharmaceutical/biotechnology industry in Mexico, with a strong understanding of the regulatory landscape.



The successful candidate will be responsible for providing strategic and tactical advice to achieve timely and efficient regulatory submissions, including NDA and life cycle maintenance. They will also engage with the broader Regulatory community within Gilead Sciences and contribute to cross-functional initiatives.



Key Responsibilities:




  • Develop and execute regulatory strategies to ensure regulatory compliance and 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 Affairs function at International project team meetings.
  • Responsible for anticipating and quantifying risks and proposing solutions.
  • Accountable for regulatory submissions and approvals, in collaboration with internal and external stakeholders.
  • Participate in trade associations interactions/meetings.
  • Accountable for establishing strong working relationships with the Regulatory central team, other functions as required.
  • Participate in or lead departmental and cross-functional taskforces and initiatives.
  • Actively monitor and anticipate trends that impact the regulatory environment and adapt regulatory strategies in a timely manner.
  • Facilitate manufacturing sites registration in line with national requirements.
  • Point contact at the cross-functional and International project team meetings.
  • Review and approve promotional materials in accordance with national legislation and Codes of Practice and company policies and procedures.
  • Establishes and supports maintenance of GDP, Importer's and Wholesaler's license and Quality Agreements related to cell/gene therapy product(s).
  • Responsible for demonstrating Gilead leadership commitments.


Requirements:




  • BSc, MSc or PhD in a scientific discipline with extensive experience in the pharmaceutical/biotechnology industry in Mexico.
  • Extensive knowledge of regulatory landscape in Mexico.
  • Experience in developing and implementing complex regulatory strategies.
  • Experience in critically reviewing complex technical documents and influencing colleagues across functions towards successful implementation of regulatory strategies.


What We Offer:



At Gilead Sciences Mexico, S. de R.L. de C.V., we offer a dynamic work environment, competitive compensation and benefits, and opportunities for professional growth and development.



How to Apply:



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



Language: Spanish

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