Summary: 

This individual is expected to provide strategic leadership within Regulatory Affairs. This person will serve as the Regulatory department representative on relevant project teams, and as the Regulatory contact with FDA and Health Canada.

Duties & Responsibilities:

•   Responsible for representing the North America regulatory function at the regulatory subteam and relevant project team meetings
•   Responsible for the development of North America regulatory strategies
•   Accountable for the implementation and execution of North America regulatory strategies
•   Accountable for regulatory submission of IND’s, NDA’s, BLA’s and other region specific submissions
•   Responsible for leading interactions with the FDA and Health Canada
•   Participates on the Regulatory subteam and is accountable for escalating issues to upper management, evaluating regulatory risks and developing mitigations plans in close cooperation with regulatory senior management

Qualifications:

A minimum 4-year degree in a scientific or technical discipline; advanced degree preferred. Must have a minimum of 7-9 years experience in Regulatory Affairs or equivalent experience within the pharmaceutical industry.

Previous experience in leading submission teams for marketing application and/or clinical trial applications is also required.

Other qualifications: Management experience is a plus. Must demonstrate a solid working knowledge of drug development process and knowledge of FDA regulatory requirements. Knowledge of EU, Canada, ROW and Post-marketing a plus. Direct experience in interacting with regulatory authorities; experience interacting with DDMAC is a plus. Candidates must be able to influence others and demonstrate strong project management, problem-solving, negotiating, interpersonal and communication skills (both written and oral).