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Regulatory Affairs Manager

hace 2 meses

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

Gilead Sciences Mexico, S. de R.L. de C.V. is seeking a highly skilled Regulatory Affairs Manager to join our team in Mexico City. As a key member of our Regulatory Affairs team, you will be responsible for developing and executing regulatory strategies to ensure compliance with applicable regulations and maximize regulatory success.

Key Responsibilities
  • Develop and implement regulatory strategies to achieve timely and efficient regulatory submissions and approvals.
  • Provide strategic and tactical advice to cross-functional teams to ensure regulatory compliance and success.
  • Engage with the broader Regulatory community within Gilead Sciences and contribute to cross-functional initiatives.
  • Collaborate with internal stakeholders to ensure the development and execution of robust regulatory strategies.
  • Anticipate and quantify risks, propose solutions, and exercise sound judgment in a timely manner.
  • Accountable for regulatory submissions and approvals, in collaboration with internal and external stakeholders.
  • Participate in trade associations interactions/meetings and establish strong working relationships with the regulatory central team.
  • 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 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.
  • Establish and support maintenance of GDP, Importer's and Wholesaler's license and Quality Agreements related to cell/gene therapy product(s).
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.
  • Self-motivator, enthusiastic, tenacious and energizing.
  • Proactive and open to share, advise and educate colleagues across the organization.
  • Agile in an evolving environment.
  • Resilient with the ability to influence and deliver in an ambiguous environment.
  • Ability to engage stakeholders and manage multiple stakeholders to achieve the objective.
  • Ability to transition from strategic to operational in order to deliver objectives according to established plans and business needs.
  • Excellent verbal & written English, negotiation, influence and interpersonal communication skills.
  • Detailed oriented.
  • A good 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.