Regulatory Affairs Manager-Consumer Healthcare OTC

Position Title Regulatory Affairs Manager-Consumer Healthcare OTC Business Division Global Specialty Operations - Consumer Healthcare Country U.S.A. Location NJ Roseland Job Description Provides overall CMC regulatory support for both new and marketed Consumer Healthcare products. This includes all CMC areas, e.g., formulation, ingredients, process, testing and stability. Provide guidance to cross-functional teams and formulate regulatory strategies for submission content. Represent CHC RA and actively participate on internal project teams and governance committees as appropriate. Review and assess critical CMC documents including Change Authorizations. Evaluate the adequacy of the content of CMC regulatory submissionsn and identify deficienciencies requiring further resolution. Prepare and maintain updated CMC dossiers for submission and archiving. Works with direct supervision or independently to assist teams in tracking regulatory activities and submissions, ensures timely completion of projects, and assists in prioritizing activities within CHC RA for CMC projects Minimal education required for this job Bachelor of Science Skills B.S. in Chemistry, Pharmacy or other scientific discipline plus 7 years related experience including 4 years relevant regulatory experience. Excellent communication skills, detail oriented and computer proficiency required. Employment Type Regular Full- or Part-Time Full-Time Work Schedule Day Requisition I.D. 24969BR

Please refer to job code 24969BR 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