Regulatory Affairs Assoc. II

Regulatory Affairs Assoc. II

Requisition ID 15900 Working Location Framingham, MA Required Education See Description Required Travel  Yes

Position Description Genzyme Corporation, ranked as one of the foremost biotechnology companies in the world, is committed to providing an exceptional environment in which individuals can excel, and achieve their professional and personal goals. Genzymes people and culture have been consistently recognized for excellence. For example, we have been named several times to Fortunes list of the 100 Best Companies to Work For in the United States. We also consistently rank among the top employers for scientists in surveys of Science readers. Genzymes local offices and facilities in Europe and other parts of the world have earned similar distinction as respected employers. By applying for a position with Genzyme, you are taking the first step toward becoming a part of our dynamic and talented team, and sharing in our continued success. The successful candidate will provide support for regulatory activities and coordination and preparation of small molecule regulatory submissions. Submissions to FDA and/or other external regulatory bodies include briefing packages, INDs, information amendments, IMPDs/CTAs and amendments thereto, NDAs, MAAs, post approval supplements or variations, and support for annual reports to INDs and NDAs as assigned, and any other program/product-related submission as applicable. The individual will be expected to stay abreast of changing regulatory requirements in order to provide guidance to project teams and participate as a team member on new development projects as well as maintenance of existing regulatory filings. The individual will also compile, organize and transcribe applicable information and data for regulatory CMC submissions for small molecule programs, World Wide (WW) as well as support and interact with various internal departments. Creates and maintains all applicable regulatory files, and source documents used to create WW files. Responsible for reviewing and signing off on proposed change controls and issuing Change Assessment Forms (CAFs) to obtain WW feedback for proposed CMC changes, tracking and filing CAFs, as well as updating, and maintaining the CMC change control reports. Required to have proficient knowledge base of cGMP requirements, and some basic understanding of US FDA post approval filing requirements. A demonstrated ability to manage tasks independently and to prioritize multiple projects. BS degree in science required with 2+ years industry experience in manufacturing, quality control and/or quality assurance preferred. Excellent communication and organizational skills as well as keen attention to detail the individual shall have also demonstrated the ability to work in a team environment. Experience with MS Word, Exel and Project applications necessary.

Please refer to job code genzyme-72374 when responding to this ad.

Category:	Biotech/Pharmaceutical
	> Regulatory Affairs
Location:	Framingham, MA
County:	Middlesex County
ZIP Code:	01701
Pay Rate:	Open
Job Terms:	full time
Company:	Genzyme
Phone:	email only please
Fax:	email only please