Regulatory Affairs Specialist

Regulatory Affairs Specialist

Ever feel burnt out by bureaucracy? Us too. That’s why we’re changing the way we work for higher productivity, faster innovation, and better results. We call it Dynamic Shared Ownership (DSO). Learn more about what DSO will mean for you in your new role here

YOUR TASKS AND RESPONSIBILITIES

• Provides regulatory support for the maintenance lifecycle management of the products of the Pharma Portfolio such as submissions on time and of complete dossiers “right at the first time” for renewals, and variations (administrative, technical and safety related), artwork reviews and support to other end-to-end regulatory activities.
• Responsible for ensuring the regulatory compliance and accomplishment of local and global KPIs of the Mexican regulatory team.
• Provides strategic regulatory support and advice to the regulatory team and internal stakeholders with an effective communication and collaboration to remove obstacles from submission preparation process and support the team in rapid filings and responses to Health Authority Questions.

WHO YOU ARE

• University Degree in Pharmaceutical Engineering, Biotechnology, Pharmaceutical Chemistry or related career.
• 3 – 4 years of senior regulatory experience within the pharmaceutical industry in navigating, interpreting and submitting complex dossiers for high specialty pharmaceutical medicines.
• Advanced English proficiency.
• Strong overview and knowledge of the current Mexican regulatory environment and regulations (medicines, biologics, orphan drugs).

WHAT WE OFFER YOU

• Hybrid Working Style.
• Attractive benefits package.
• Wide range of development opportunities.
• Good working conditions and comfortable working environment.

At Bayer, we believe in diversity, equity, and inclusion. We aim to create an environment in which everybody can feel authentic, respected, and equally valued. Every day we strive to reflect our values through our people's unique capabilities, self‑experiences, and aspirations. We intentionally seek diversity, to enable our people to bring their fullest potential out and encourage others to likewise do so. Our company wins when we leverage our capabilities to lead the cultural transformation in our business, positively impacting society.

Candidates who meet the requirements based on the job profile will be considered for employment regardless of physical disability, race, color, religion, sex, age, sexual orientation, or gender identity and will not be at a disadvantage if unemployed.

Application Period: 07/15/2026 - 07/28/2026

Reference Code: 877299

Division: Pharmaceuticals

Location: Mexico : Ciudad de México : Ciudad de México