Regulatory Affairs Manager

Seniority Level: Manager

Modality: Hybrid

Position Overview

We are seeking an experienced Regulatory Affairs Manager to lead the development and execution of regulatory strategies ensuring the full compliance of our product portfolio—nationally and internationally. This includes bioequivalent and bioavailability drugs, medical devices, controlled substances , and imported products .

You will act as the key liaison with health authorities such as COFEPRIS, FDA, EMA , as well as international customs and regulatory entities , facilitating agile, safe, and legally sound access of products to the market.

Key Responsibilities

• Design and implement regulatory strategies for the registration, importation, and lifecycle management of pharmaceutical products and medical devices.
• Coordinate the preparation and submission of dossiers for new registrations, renewals,...