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 remo...