Regulatory Pharmacist, San Juan

The Regulatory Affairs Pharmacist is responsible for ensuring that all pharmaceutical products comply with local and international regulatory requirements.

This role involves preparing, reviewing, and submitting documents to government health authorities, monitoring regulatory changes, and supporting product registrations, renewals, and compliance activities.

Key Responsibilities:

• Prepare, compile, and submit product registration dossiers, variations, and renewals to the FDA and other regulatory agencies.
• Ensure compliance with regulatory guidelines, laws, and standards governing pharmaceutical products.
• Maintain and update regulatory files and databases to track submissions, approvals, and licenses.
• Review product labels, packaging, and promotional materials to ensure compliance with regulations.
• Monitor and interpret regulatory changes and provide guidance to management and other departments.
• Coordinate with cross-functional teams (QA, R&D, Marketing, Manufacturing) to ensure regulatory requirements are met.
• Handle product recalls, adverse event reporting, and other regulatory-related activities when necessary.
• Serve as liaison between the company and regulatory authorities.