Mgr/Sr. Manager Regulatory Affairs

Manager/Sr. Manager Regulatory Affairs
This position fulfills an important role in the company and the Regulatory Affairs department. It demands solid experience in the pharmaceutical industry and, in particular, US regulatory affairs.  The successful candidate must have scientific judgment and good writing ability as well as demonstrate good teamwork and solid internal/external communication. A significant part of this position will be the ability to represent the department in meetings in lieu of the Director of Regulatory Affairs and Drug Safety in the event of schedule conflict. Specifically, requirements for the position will include (but are not limited to): Providing recommendations and advice to internal customers on the U.S. regulatory aspects of development and registration of drug products, providing overall operational leadership and coordination of day-to-day regulatory affairs activities, preparing and submitting IND applications and providing leadership to junior regulatory affairs and administrative staff in constructing and submitting updates to IND's, including Investigator Brochures, Annual Reports, and Briefing Books for FDA meetings. The candidate will interact with DRA/DS and regulatory staff to streamline procedures for submission coordination and documentation. The incumbent will work with the DRA/DS to report Serious Adverse Events to regulatory authorities as required.  Will work with U.S. Regulatory Affairs to build regulatory infrastructure including: SOPs, documentation methods, forms, optimal methods of interacting with other departments, and consultant network review.  The candidate will contribute to regulatory strategy documents as requested and assist in planning and preparation of NDAs and ANDAs in CTD format.  Will provide training in US regulatory affairs and maintain current regulatory affairs and technical knowledge through review of FDA website, trade newsletters, and scientific publications and through attendance at webcasts, advisory committee meetings and conferences as appropriate

Please refer to job code SD6539 when responding to this ad.

Category:	Biotech/Pharmaceutical
	> Regulatory Affairs
Location:	Pluckemin, NJ
County:	Somerset County
ZIP Code:	07978
Pay Rate:	Open
Job Terms:	full time
Company:	The Cambridge Group Ltd.
Phone:	E-mail or fax only
Fax:	203-226-3856