Regulatory Affairs Coordinator, NDA

An exciting and challenging permanent opportunity has opened up for a Regulatory Affairs CMC Manager. 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 gauge appropriate CMC Strategy decisions. 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.

- Provide CMC regulatory support for global brand expansion including
-Communicate regulatory strategy to project teams for assigned products
- Track CMC sections of NDAs, INDs and Annual Reports
-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.

RESPONSIBILITIES:

-Preparation and coordination of regulatory submissions for marketed products
-Strong working knowledge of FDA CMC regulations
-Knowledge of guidelines and requirements including NDA and IND compilation and filing requirements
-Communicate regulatory strategy to project teams for assigned products
-Liaises with regulatory, manufacturing and other parties as appropriate
-Lead regulatory team meetings
-Plan, prepare, and track, submissions to regulatory agencies.
- Bachelor's degree in a relevant discipline, with 6+ years of experience
-Proven significant experience in Regulatory Affairs.
-Experience in the submission of regulatory documentation
-Direct experience working with Regulatory Authorities
-Excellent organization skills and ability to multi-task
-Ability independently manage workload

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