Director, Medical​/Regulatory Writing

Regulatory Affairs Manager

Location:

Guadalajara, Jalisco / Mexico City
Modality:  Hybrid

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.

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, modifications, and controlled product procedures before COFEPRIS and other agencies.
Manage  prior import permits  , including those for controlled substances and regulated raw materials.
Ensure compliance with  Mexican Official Standards (NOMs) ,  ICH guidelines  , and other applicable international regulations.
Oversee documentation processes, including  import notices, labeling, certificates of analysis  , and  free sale certificates  .
Collaborate closely with  quality, logistics, and customs  teams to guarantee efficient product flow and regulatory alignment.
Develop and maintain the  Quality Management System Manual  , ensuring compliance with  Good Manufacturing, Documentation, Storage, and Distribution Practices  .
Represent the company before regulatory bodies and participate in  sectoral forums or working groups  .
Maintain up-to-date  regulatory databases  and lead  training efforts  for the internal regulatory team.

Bachelor’s degree in  Pharmaceutical Chemistry, Biotechnology, Pharmacy  , or related fields.
Master’s or specialization in  Regulatory Affairs, Foreign Trade  , or  Health Legislation  .

Minimum 5–7 years  in regulatory affairs within the  pharmaceutical industry  , handling medicines, controlled substances, and medical devices.
Familiarity with  foreign trade laws  , COFEPRIS regulations, and applicable treaties.
Regulatory handling of  controlled substances  (psychotropics, narcotics).
Advanced English  is essential;
Join a mission-driven team shaping regulatory excellence on a global scale.