Regulatory Affairs Senior Strategy Associate

A permanent opportunity has opened up for a Regulatory Affairs Senior Strategy Associate. The Senior Associate should be able to prepare, review and submit high quality, regulatory submissions to the FDA and health authorities. The role will require participating in pre-IND meetings, as well as liaising with the FDA and other groups.

The right candidate should be ambitious and hard working and ideally be able to quickly develop some project management experience.

-Strong communication skills
-Assist in various INDs, NDAs, renewals, labelling updates and variations.
-Communicate regulatory strategy to project teams for assigned products
-Lead other associates and train them to review and prepare basic regulatory documents.
-Evaluates changes to regulatory documents and formulates strategies to maintain submission goals.
-Other duties, as assigned, or as business needs require.
-Maintains compliance with regulatory requirements for drugs for theUSmarket.
-Assist in regulatory activities in both foreign and domestic markets

To find out more about Real Staffing please visit www.realstaffing.com