Regulatory Affairs Coordinator

About the role

The Regulatory Affairs Coordinator will work closely with therapeutic area teams and local stakeholders to ensure that all regulatory dossiers, labeling, and advertising materials comply with local health authority requirements. This position supports the submission of new product applications, variations, renewals, and label updates, contributing to timely market authorizations.

Key responsibilities

• Coordinate preparation and submission of dossiers to the local Health Authority for marketing authorizations, variations, and renewals.
• Manage label update projects, ensuring alignment with reference labels and KPI timelines.
• Review and approve advertising, promotional, and non‑promotional materials for regulatory compliance.
• Oversee GMP, CPP, PoA, LoA, and other legal document validity throughout the product lifecycle.
• Prepare advertising application files for Cofepris submission and schedule submission dates with Marketing.
• Update global regulatory systems according to defined timelines.
• Review and validate Spanish translations of technical, legal, and clinical documents.
• Maintain archives of GMPs and related regulatory documents.

Required profile

• Experience in regulatory affairs within the pharmaceutical or biotechnology sector.
• Familiarity with local health authority regulations and submission processes.
• Strong organizational skills to coordinate cross‑functional activities and meet deadlines.
• Ability to work with Spanish‑language documentation and translations.

Required skills