Regulatory Affairs Executive (Mexico Market)

Role & responsibilities (Maxico Market)

• Prepare and coordinate regulatory submissions for pharmaceutical products to COFEPRIS.
• Support preparation and compilation of dossiers for new product registrations, renewals, variations/modifications, and other applicable regulatory procedures.
• Provide regulatory support to cross-functional teams.
• Handling of deficiency responses of Marketing Authorization Applications
• Communicate with partners for timely information availability
• Ensure timely submission of variation and commercial urgency requests to relevant regulatory authorities
• Maintenance of different project trackers
• Renewals and other applicable lifecycle activities

Preferred candidate profile

• 2 to 7 Years of experience required in RA
• Required experience in Mexico Market.