Regulatory Affairs Manager

Regulatory Affairs Manager

Location:

Guadalajara, Jalisco / Mexico City
Industry:
Pharmaceutical
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, 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.
Lead   regulatory audits   , manage responses, and ensure timely implementation of corrective actions.
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.

Required Profile:

Education:

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

Experience:

Minimum  5–7 years   in regulatory affairs within the   pharmaceutical industry   , handling medicines, controlled substances, and medical devices.
Proven expertise in   import procedures, prior permits   , and   customs regulation   .
Experience managing   regulatory platforms   (Digipris, VUCEM, CECI).
Solid relationships with   COFEPRIS, SSA, Customs   , and international agencies.

Technical Knowledge:
Comprehensive understanding of   national and international health regulations   (NOMs, ICH, FDA, EMA, WHO).
Familiarity with   foreign trade laws   , COFEPRIS regulations, and applicable treaties.
Regulatory handling of   controlled substances   (psychotropics, narcotics).
Knowledge in   clinical studies   and   bioavailability/bioequivalence documentation   .
Advanced English   is essential; a second language is a strong asset.

Core Competencies:

Strong   technical and regulatory expertise   .
Leadership, strategic thinking   , and decisive execution.
Clear and assertive   communication skills   , both internally and with authorities.
Risk management   and problem-solving in complex regulatory scenarios.
High standards of   organization, precision   , and   ethical responsibility   .

Why Join Us?
We offer a competitive compensation package and   industry-leading benefits   in the pharmaceutical sector. Join a mission-driven team shaping regulatory excellence on a global scale.

Apply today and make an impact!