Regulatory Strategy Coordinator Lead

hace 23 horas


San José, San José, Costa Rica Pfizer A tiempo completo
Job Overview

Pfizer is committed to excellence in the field of regulatory affairs. As a key member of our team, you will play a vital role in ensuring compliance with local and international regulations.

Key Responsibilities:

  • Participate in the development and implementation of regulatory strategies for product submissions and lifecycle management.
  • Coordinate and execute activities related to dossier planning and submission - paper and/or electronic - for initial registration and maintenance of drug products.
  • Interact with internal stakeholders to ensure the execution of regulatory strategies according to plan, facilitating business continuity.
  • Support senior managers in defining and executing regulatory strategies for assigned portfolios.
  • Collaborate across regions to deliver efficiencies in regulatory submissions and processes.

Requirements:

  • Understand local market regulatory requirements and processes.
  • Coordinate activities related to drug product submissions and license maintenance to health authorities.
  • Work in partnership with country regulatory teams and stakeholders to ensure the development and implementation of regulatory strategies.
  • Maintain awareness of local regulations and trends.
  • Ensure timely updates of regulatory information on Pfizer systems and databases.
  • Review submission-ready dossiers to ensure compliance with local regulatory requirements.
  • Support bidding processes by providing updated regulatory documents.
  • Evaluate and stay informed about BoH regulations and changes.
  • Review and approve promotional materials to ensure compliance with SOPs and local requirements.
  • Collaborate with labeling and artworks approval processes according to Pfizer procedures and local regulations.
  • Complete departmental training to address corporate and regulatory needs.

Qualifications:

  • Pharmacist graduate or life science degree.
  • Local regulatory experience.
  • Minimum 4 years of experience as a Regulatory Affairs Analyst (Human Medicinal Products).
  • Proven ability to consistently deliver on time and quality standards.
  • Proven ability to manage complex regulatory issues.


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