Regulatory Affairs Specialist – Pharma (Mexico City)

About the role

Join Bayer's Pharmaceutical division in Mexico City as a Regulatory Affairs Specialist. You will support the lifecycle management of pharma products, ensuring timely and complete submissions for renewals, variations, and artwork reviews while collaborating with local and global teams.

Key responsibilities

• Prepare and submit regulatory dossiers for product renewals, administrative, technical, and safety variations.
• Conduct artwork reviews and support end‑to‑end regulatory activities.
• Ensure compliance with Mexican regulations and achieve local and global KPI targets.
• Provide strategic regulatory advice to internal stakeholders and facilitate rapid filings.
• Respond to Health Authority inquiries and remove obstacles in the submission process.

Required profile

• University degree in Pharmaceutical Engineering, Biotechnology, Pharmaceutical Chemistry or a related field.
• 3–4 years of senior regulatory experience in the pharmaceutical industry.
• Advanced proficiency in English.
• Strong knowledge of the current Mexican regulatory environment for medicines, biologics, and orphan drugs.

Required skills

What we offer

• Hybrid working model.
• Competitive salary and attractive benefits package.
• Wide range of development opportunities.
• Comfortable working environment with a focus on diversity, equity, and inclusion.