Regulatory CMC Associate Manager

• 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