Senior Regulatory Affairs Expert, Rx

Main Responsibilities:

· New products registration;

· Regulatory product life cycle management (variations submissions and approval incl. new indications, new manuf. sites etc.);

· Tracking of variations is regulatory database (Insight);

· Regulatory compliance: CCDSs timely submissions and tracking;

· Trackwise for Change control implementation for Russia;

· Tracking of labelling updates in LIFT database;

· InSignt Database maintaining for Russia;

· ND remediation project support;

· Regulatory support of CVT: promotional and educational materials approval in iMedical Review system

We offer:

· Competitive salary & annual bonus

· Medical and life insurance

· Meal allowance

· Fitness compensation

· Mobile allowance

· Opportunities for professional development and growth

Requirements:

· Higher Education (Pharmacy sphere is preferable)

· From 2 years’ of relevant experience in a pharmaceutical company (regulatory roles with relevant responsibilities)

· Experience in registration of original products;

· In depth knowledge of regulations/legislation;

· English – upper intermediate