Our client is a top 10 pharmaceutical company that has established a reputation as one of the most desirable organizations to work for in North America. With a demonstrated commitment to ongoing scientific innovation and an empowering corporate culture that is focused on rewarding top performers, this is a strong opportunity for the right candidate!

Job Responsibilities:
1) Provide US regulatory strategic direction as the US Regulatory Lead of Global/US Product for projects of moderate complexity and/or discrete components (i.e. line extensions, new indications) of larger projects
2) Serve as the principal interface with primary reviewers from health authorities (e.g. FDA)
3) Develop regulatory strategies
4) Provide direction on health authority interactions
5) Prepare regulatory submissions
6) Demonstrate leadership in the team and within the function to accomplish business objectives
7) Coordinate activities of small groups of local PDR personnel to ensure that tasks are completed within defined due dates as well as meet regulatory and departmental guidelines
8) Manage special regulatory projects of moderate complexity (as assigned by others)

Job Requirements:
1) Bachelor’s degree with Master's degree or Ph. D. highly preferred
2) 3 – 5 years of relevant experience in drug development including expertise in regulatory affairs with successful NDA submissions
3) Basic working knowledge of core processes – discovery, development, manufacturing and marketing
4) Excellent leadership, communication (written and oral), organizational, interpersonal and team skills
5) Commitment to performance measures of time, costs and quality

Applicants are encouraged to apply directly by going to: http://www.sterlinglifesciences.com/jobs/lifesciences-jobs-03266.html