Pharmacist – Regulatory Affairs

About the role

We are seeking a licensed pharmacist to lead regulatory affairs within our organization. The role focuses on ensuring compliance with FDA regulations and managing product registrations, renewals and variations.

Key responsibilities

• Interpret and apply FDA regulations to maintain product compliance.
• Prepare and submit renewal, variation and other regulatory dossiers on schedule.
• Coordinate with government agencies, suppliers and internal stakeholders to gather required information.
• Deliver product knowledge training and educational sessions for internal teams, sales staff, distributors and business partners.
• Manage multiple regulatory projects simultaneously, ensuring timely completion.

Required profile

• Licensed pharmacist with experience in regulatory compliance.
• Strong organizational abilities and capacity to work independently.
• Excellent presentation and communication skills for conveying technical information.

Required skills