Regulatory CMC Associate Manager

Company DescriptionArtech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.Job Description• Assist and support regulatory CMC managers in the following activities:• Defining global CMC regulatory strategy and decisions for development projects or marketed products to achieve optimal submission/approval results and ensure regulatory compliance.• Communicating CMC regulatory strategy, key issues and remediation activities needed throughout the project/product life cycle, to project teams and appropriate management levels within and outside of Reg CMC.• Influencing and negotiating within cross-functional teams to ensure quality submission planning and decision-making.• Single point of contact with other line functions• Review CMC regulatory documentation to ensure strategic direction and regulatory compliance are met.• Collecting documentation from other line functions to support submission preparation• Ensure databases are maintained to complianceQualificationsSkills:Desirable: Experience in regulatory field, in particular regulatory CMCEducation:Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalentDesirable: Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent.Additional InformationBest Regards,Anuj Mehta973-967-3402SummaryType: ContractFunction: ScienceExperience level: Mid-Senior LevelIndustry: Pharmaceuticals