Director, Regulatory Affairs
The Regulatory Director will influence organizational decisions that involve multiple groups and/or locations.
Essential Duties and Responsibilities (include but are not limited to)
Implement and Manage all Regulatory activities required to bring new drugs into the clinic and through development to NDA stage.
Develop strategies to ensure the earliest possible approvals by FDA, HPB, European and other regulatory authorities.
Provide guidance to senior management and department heads within Research, pre-clinical and Clinical development areas on all regulatory issues for the planning, compilation and submissions of INDs and NDA/MAA. Primary company contact with Regulatory Agencies for assigned projects.
BS or advanced degree (in any biological science) with a minimum of 10 years of regulatory experience in the pharmaceutical industry or biotechnology industry.
Must have comprehensive experience of small molecule drug development and significant experience interacting directly with FDA and other regulatory agencies.
Must have demonstrated experience submitting and negotiating the approval of INDs, NDA, or equivalent.
A strong background in Regulatory CMC is strongly desired.
Ability to work cohesively across functions with multi-disciplinary scientific working groups is a must.