Principal CMC Regulatory Support Associate

At Kforce Clinical Research, we dont just offer jobs. We offer a rewarding career experience, complete with professional development opportunities and a great benefits package! We are intelligent business partners to some of the worlds most valued pharmaceutical companies and have evolved to create models of operational excellence that incorporate Lean and Six Sigma philosophies. Using these tools, Kforce is able to better plan and anticipate work loads and thus minimize the peaks of work that can swamp you. This allows you to stay just as dedicated and still strike a balance between work and home. Currently, one of our top clients is in search of an exceptional Regulatory Support Associate in Bridgewater, NJ. The Regulatory Support Associate will be responsible for generating the technical content for the Chemistry, Manufacturing, and Controls (CMC) documentation required for investigation new drug applications and their respective amendments. Specific Accountabilities: * Coordinate the completion of the CMC templates with the Regulatory Affairs (CMC) Organization for those filings assigned * Summarize technical reports and documents to meet the needs of a given template section * Maintain a working knowledge of the project plans for those projects where you are a contributor to ensure that the CMC sections are delivered on time * As required, serve as a member of multi-disciplinary teams organized to ensure project timelines are met and clinical and commercial supplies are available when needed. * Assist the manager with the mentoring of the teams less experienced members * Assist the manager with the preparation of an optimized work flow for document creation, review and completion Requirements: Due to the precise requirements of this position, we will only be contacting candidates that meet all of the listed criteria. Experience: * A minimum 15 years of biopharmaceutical or pharmaceutical industry experience which should include a minimum 5 years of regulatory including handling / authoring regulatory documentation or related experience * Working knowledge of the regulatory requirements for the U.S., Europe, and Japan * Working technical knowledge of the biopharmaceutical manufacturing process preferably in the area of antibody manufacturing * BS/BA degree in Biochemistry, Chemistry, Microbiology, Pharmaceuticals, Chemical Engineering, or related field * Working knowledge of cGMPs as they apply to the Regulatory environment * Strong organizational and project management skills * Excellent communication skills (oral and written) with demonstrated skills in the preparation of complex regulatory filings * Demonstrated supervisory skills Travel Requirements: * Up to 10% Kforce Clinical Research has been serving the pharmaceutical industry since 1988. We are truly a career destination and the employer of choice for skilled, dedicated professionals like you. At Kforce, one of our core principles is: Great People = Great Results! This means that we will work to find you the right career match through exceptional customer service, a disciplined process, and personal respect. If you are qualified and interested in the excellent career opportunities we have for you, apply today!

Please refer to job code 1696NRC950551P199 when responding to this ad.

Category:	Education/Training
	> Principal
Location:	Bridgewater, NJ
County:	Somerset County
ZIP Code:	08807
Pay Rate:	Open
Job Terms:	full time
Company:	Kforce Inc.
Phone:	email only please
Fax:	email only please