Employment

Position Summary:

Manage and direct the company's Global Regulatory Affairs, including selection of geography for conduct of trials, planning and implantation of submissions, and maintenance of relations with agencies in Europe, the Americas and Asia

Location:

Boston Area

Functions:

• Guide portfolio development and partnership opportunities
• Develop short- and long-range regulatory plans and strategies for each of the assets in Flexion's portfolio
• Direct all regulatory filings, manage CROs in that process
• Serve as primary interface with FDA and other regulatory agencies
• Develop processes that ensure adequacy of regulatory documentation
• Serve as an integral member of the development team

Education:

B.A. required, advanced degree preferred

Experience:

Minimum 10 years experience in the industry, five years in regulatory including extensive interaction with regulatory agencies

Skills:

• Expert knowledge of scientific principles and concepts underlying drug development
• Strong leadership and management skills
• Excellent teamwork and collaboration skills
• Effective process and project management skills
• Outstanding written and verbal communication skills
• Ability to deal with the complexities as needed in a start-up environment