Sr. Regulatory Associate

Description

This position will provide regulatory support for the project teams for all aspects of generic product development, including bioequivalence, manufacturing (CMC) issues, post-marketing safety reporting and advertising and promotion. Both early and late-stage projects will be supported. This position will play a leadership role in the coordination of domestic and international regulatory submissions.

Responsibilities

· Attend project team meetings across functional areas· Prepare, submit, and maintain domestic regulatory fillings (ANDAs, INDs, NDAs) both pre and post approval.
· Coordinate meetings with regulatory authorities.
· Assist with development strategy.
· Support the filing, review, and approval of global license applications.
· Support for multiple projects if necessary.
· Other duties as assigned.
REQUIREMENTS
· BA/BS degree.
· 2-4 years experience in Regulatory Affairs.
· Proven ability to manage critical projects with a minimum of supervision.
· Prior experience compiling filings for FDA submissions is required with the ability to successfully manage projects to deadlines.
· Prior experience in a product development role and experience with drugs, specifically generic drugs, is desirable.
· Proficient with computer and standard software programs.
· Strong interpersonal and communication (written and verbal) skills.
· Effective task planning and coordination abilities.
· Demonstrated good judgment.
· Capable of working with an interdisciplinary team.