Regulatory Affairs Specialist

About the role

The Regulatory Affairs Specialist will ensure that Bayer's pharmaceutical activities in Mexico comply with all relevant laws, regulations, and standards. You will develop and implement regulatory strategies, prepare submissions, and act as a key liaison with health authorities.

Key responsibilities

• Provide regulatory support for the product lifecycle, including timely submissions of renewals, variations, and artwork reviews.
• Prepare and submit permits, licenses, certificates, and other authorizations required by Mexican governmental agencies.
• Coordinate interactions with regulatory agencies and ensure alignment with internal stakeholders.
• Monitor and achieve local and global KPIs for the Mexican regulatory team.
• Offer strategic advice to internal functions to remove obstacles and accelerate filing processes.

Required profile

• Degree in Pharmaceutical Science or a related field.
• Senior regulatory experience in the pharmaceutical industry, handling complex dossiers for specialty medicines.
• In‑depth knowledge of the Mexican regulatory environment for medicines, biologics, and orphan drugs.
• Strong written and verbal communication skills in English (minimum B2 level).

Required skills

• Regulatory dossier preparation and submission.
• Interpretation of Mexican pharmaceutical regulations.
• Stakeholder coordination across Regulatory Affairs, QA, Pharmacovigilance, Clinical Operations, and Manufacturing.

What we offer

• Competitive compensation and benefits package.
• Opportunity to work within a global pharmaceutical leader.
• Collaborative environment focused on innovation and compliance.