Sr. Regulatory Affairs Associate

Position Title Sr. Regulatory Affairs Associate Business Division Global Specialty Operations - Consumer Healthcare Country U.S.A. Location NJ Roseland Job Description The Sr. Regulatory Affairs Associate is responsible for review and approval of OTC labeling and promotional material; ensures regulatory compliance for currently marketed brands and new products; is a key member of a number of cross-functional teams working on both the development of product claims for labeling and promotion as well as commercialization of new products; provides regulatory support/coordination of regulatory projects and researches regulatory issues, e.g. monograph status, labeling.  Responsible for maintaining US & International IND and NDA dossiers and for preparation of IND and NDA annual reports.

Minimal education required for this job Bachelors Degree -- Any Skills ? Bachelors Degree required ? Minimum of three years Regulatory Affairs experience or 5 years experience directly related in the pharmaceutical or consumer products industry. ? Experience with NDA and IND drugs plus knowledge of OTC monograph system and OTC drug/cosmetic regulatory requirements highly desired. ? The successful candidate must have excellent communications skills, be detail-oriented and have strong PC skills. Employment Type Regular Full- or Part-Time Full-Time Work Schedule Day Requisition I.D. 24959BR

Please refer to job code 24959BR when responding to this ad.

Category:	Biotech/Pharmaceutical
	> Regulatory Affairs
Location:	Roseland, NJ
County:	Essex County
ZIP Code:	07068
Pay Rate:	Open
Job Terms:	full time
Company:	Schering-Plough
Phone:	email only please
Fax:	email only please