Regulatory CMC Associate Manager

ArtechInformationSystemLLC

East Hanover, NJ, United States contract

Posted: December 2, 2015

Job Description

Artech 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.

• 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 compliance

Skills:

Desirable: Experience in regulatory field, in particular regulatory CMC

Education:Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent

Desirable: Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent.

Best Regards,

Anuj Mehta

973-967-3402

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