Regulatory Science Expert

hace 7 días


Xico, México Pfizer A tiempo completo
About the Role

We are seeking a highly skilled Regulatory Science Analyst to join our team at Pfizer. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring the compliance of our products with local and global regulations.

Key Responsibilities
  • Interact with key stakeholders to perform activities related to product lifecycle maintenance.
  • Develop and submit product registration, progress reports, supplements, amendments, and periodic experience reports.
  • Contribute to the completion of project milestones and organize own work to meet project task deadlines.
  • Ensure compliance of the team to submission standards, procedures, and policies framed by Global Regulatory Affairs.
  • Prepare, support, and finalize Global Regulatory Strategy Documents (GRSD), variations for Lifecycle Management (LCM) submissions, and ensure effective data presentation and quality.
  • Maintain required regulatory databases to ensure compliance.
Requirements
  • Bachelor's Degree
  • Experience: about 1 year as Regulatory Affairs Analyst
  • Good skills on communication, collaboration, negotiation, and problem-solving
  • English, written and spoken
  • Computer literacy and ability to learn new systems
Preferred Qualifications
  • Knowledge of regulatory processes and documents
  • Knowledge of therapeutic areas
  • Change Agile
  • Team player
About Pfizer

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.



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