Regulatory Affairs Associate

52949 - Regulatory Affairs Associate

Who we are:

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity:

Prepare submissions for US, EU and CA markets, respond to deficiency letters, support pre-launch activities.

How you’ll spend your day

• Prepare regulatory submissions for generic products or US, EU and CA markets
• Respond to deficiency letters and coordinate related activities
• Provide regulatory guidance, support and resolve issues raised during product development and review period
• Support pre-launch activities

Your experience and qualifications:

• Bachelor degree in the field of science (e.g., chemistry/chemistry engineering, biothechnology/biotechnology engineering, pharmacology)
• Master's degree - advantage
• 3 year experience in Regulatory Affairs in a pharmaceutical company - must