Sr. Manager, Regulatory Affairs

Where

Cambridge, MA

What you'll be doing

The sr. manager (regulatory affairs) will lead the integration of regulatory strategy and tactics in the development of the company core data sheet and associated documents. Establish innovative strategies for achieving regulatory compliance for global prescribing information. Strategically assess global prescribing information activities and support cross-functional team decisions making for these activities. Execute effective decision-making, planning and project management in the development and life-cycle management of the company core data sheet. Perform other duties as assigned.

What your background should be

Minimum 8 years regulatory or relevant industry experience, including 2 years management experience. Experience in interpretation of global labeling regulations and precedence. Demonstrate excellent leadership, communication, and presentation skills. Ability to represent the department on cross-functional teams and effectively interact with global counterparts. Ability to build capability through coaching and mentoring.

Required Schooling / Training

BA/BS university degree required.

Who is the client company

This is an American global biotechnology company.

If you are interested in this position, send your resume to apply@kochdavis.com