Cmc Principal - (US-NJ-Peapack - 07977)

Minimum Education: None
Job Type: Full Time
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Responsibilities and Requirements : Bachelors degree in a scientific discipline (e.g.,chemistry, biology, pharmacy); advanced degree in scientific discipline preferred. - 5 years pharmaceutical regulatory or compliance experience with demonstrated project management, interpersonal, and leadership skills. -Qualified candidates must possess excellent communications skills (both written and verbal), with strong technical and regulatory writing ability. -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. /Job Description: Core responsibilities include, but are not limited to: -preparate 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 of registered commitments and site manufacturing/testing practice; -manage post-approval manufacturing changes for products manufactured at facilities and contract manufacturers; -prepare responses to Health Authority queries and requests for CMC information, as appropriate; -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.

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