Regulatory Affairs Coordinator

Added
1 day ago
Type
Full time
Salary
Salary not provided

Related skills

spanish english regulatory affairs gmp veeva

📋 Description

  • Coordinate activities with Area Therapeutic Area Teams and local stakeholders to ensure dossier
  • Coordinate label update activities based on reference label and KPIs timelines.
  • Review and approve advertising, promotional and non-promotional materials per regulations and
  • Coordinate with Area Therapeutic Area Teams to ensure GMPs issued by local Health Authority for
  • Maintain GMPs, CPPs, PoAs, LoAs, and other regulatory documents with certified copies and archiving.
  • Prepare files for submission to local Health Authority and update global regulatory systems.

🎯 Requirements

  • Education: Bachelor degree (Pharmacist, Biotechnology Engineer, Pharmaceutical Engineer or related).
  • 2 to 5 years in a similar position.
  • Knowledge of Health regulation in Mexico.
  • Good communication and stakeholder relationship skills; fluent in English (written and spoken).
  • Strong tracking of activities and translations to Spanish as needed.

🎁 Benefits

  • AbbVie Equity and comprehensive benefits package as per local policies.
  • Opportunity to work with cross-functional teams in a global pharmaceutical company.
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