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Associate, Regulatory Affairs CMC III

Company: Ascent
Location: San Rafael
Posted on: January 8, 2019

Job Description:

Associate, Regulatory Affairs CMC III San Rafael, CA This position focuses on the management of CMC regulatory activities for an enzyme substitution therapy program for domestic and international regulatory affairs. The role involves working closely with in-house CMC teams, partners, contract manufacturing organizations, and global health authorities to ensure rapid review and approval of the CMC portions of marketing applications, amendments, supplements/ variations, and other CMC-oriented filings. this position is also responsible for obtaining and interpreting CMC regulations and guidance and providing regulatory advice to technical operations departments Skills Expertise with biologics and/or drug/biologic/device products is strongly preferred. Strong communication and management skills are required. Oversee planning, preparation, and submission of the CMC sections of marketing applications globally. Ensure that the sections are accurate, complete, well-written, and meet all relevant country-specific requirements. Develop excellent relationships with internal functional groups, contract manufacturing organizations, and partners. Researching and interpreting global CMC regulations and providing regulatory guidance to the Quality, Manufacturing, Process Development and other functional groups. Excellent organization skills. Attention to detail. Understanding of ICH guidances and CMC regulations. Company Description: About Ascent: Ascent is a leading national technology consulting and professional services firm that focuses on tactical and strategic consulting. Ascent's fundamental business is providing staffing services to Large Enterprise clients in our core market verticals: Financial Services, Healthcare, and Life Sciences. We focus the majority of our efforts in Staff Augmentation support of Large Enterprise Clients who utilize a Vendor Management System. Ascent works as both a reliable supplier in support of programs, as well as a Strategic Advisor in support of enterprise efforts to establish best in class preferred vendor programs. Ascent was ranked in the 2007 and 2008 Inc. 500 and recognized specifically for its innovative work in staff augmentation support of Large Enterprise preferred vendor accounts. If you are ready to propel your career to new heights--- read on. We are looking for talented and dedicated colleagues to join our phenomenal team. At Ascent, we have created an environment where culture, commitment and opportunity converge to yield a truly unique place to work. We know that every employee has something important to say and that every employee is integral to our success. Where else can you walk over to a founder and talk about your ideas to help build our business and have that idea implemented in 48 hours? More importantly, we do everything we can to make sure our employees not only have great jobs, but great lives.

Keywords: Ascent, San Rafael , Associate, Regulatory Affairs CMC III, Other , San Rafael, California

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