Regulatory Affairs CMC Project Manager

Job description: 

Manages multiple multi-product CMC focus global submission to ensure timely completion per established timelines. In consideration of health authority requests & program plans, create project plans with documentation requirements, timelines, and identified and monitor activities of key deliverables. Will work closely with project leads, but require the ability to work independently with minimal supervision. Requires excellent verbal and written communication skills, must be able to manage concurrent projects that may be unplanned, detailed oriented, and organized. May require internal and external interactions in support of project plans. 

 

Education Skills:

 

Professional Degree and/or coursework (Chemistry, Biology, Biochemistry, Pharmacy, etc) and at least one year of regulatory related course work is preferred. 

Proficient in MS Office and experience in databases and electronic system is highly desirable.