Manager Regulatory Affairs

An exciting and challenging permanent opportunity has opened up for a Regulatory Affairs Senior Associate. The Senior associate should be able to prepare, review and submit high quality, regulatory submissions to the FDA. Submissions include NDAs, INDs, amendments, supplements, annual reports and additional documents

The right candidate should be ambitious and hard working and ideally be able to quickly develop some project management experience. Communication skills are vital, and a candidate should be able to interact effectively with business units in order to coordinate facilitate documentation required for submissions.

-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 the US market.
-Assist in regulatory activities in both foreign and domestic markets.

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