CMC Principal

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 A CMC Principal in Peapack, NJ. Responsibilities/Job Description: * Prepare and update the CMC sections of global Marketing Authorizations * Develop regulatory post-approval filing strategies and variations for global products * Ensure support to market affiliates for license renewals and annual reports, line extensions and territory expansions * Ensure that all regulatory documents are prepared accurately, completely and on-time * Manage completion of compliance assessments on product dossiers and develop and implement specific filing strategies to ensure compliance * Maintain fluency in emerging global CMC regulations and content/format requirements * Provide general support to market affiliates with regard to CMC issues; develop strong working relationships and act as primary Global CMC interface with global Regulatory Affairs colleagues and manufacturing sites Requirements: CMC Principal Qualifications: * Minimum Bachelors degree in a scientific discipline (advanced degree in scientific discipline preferred) * Minimum of 5 years of pharmaceutical regulatory or compliance * Excellent communications skills (both written and verbal) * Proven experience in multi-tasking and prioritizing projects * Strong global knowledge in post-approval Chemistry, Manufacturing, and Controls (CMC) change regulations, and in the content and structure of the CMC section of a Marketing Authorization * Ability to participate as CMC representative on cross-functional project and co-development teams, and effectively work with multiple disciplines and personalities * Candidate must have a thorough understanding of regulatory change management requirements * Possess a strong working knowledge of FDA regulations and other global authorities CMC requirements Due to the precise requirements of this position, we will only be contacting candidates that meet all of the listed criteria. 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. If you are qualified and interested in the excellent career opportunities we have waiting for you, apply today!

Please refer to job code 1696NRC950561T199 when responding to this ad.

Category:	Education/Training
	> Principal
Location:	Peapack, NJ
County:	Somerset County
ZIP Code:	07977
Pay Rate:	Open
Job Terms:	full time
Company:	Kforce Inc.
Phone:	email only please
Fax:	email only please