Regulatory Affairs Director

Regulatory Affairs Director

Frontage Laboratories, Inc is one of the fastest growing contract research organizations in the world, with operations in Pennsylvania, New Jersey, and China. Currently we have the following Regulatory Affairs position open in our Malvern, PA site.

The Regulatory Affairs Director will provide regulatory guidance during the development of the branded and generic products and ensure that development and filing activities adhere to current U.S. regulations and guidelines.  You will manage and execute timely filing of high quality electronic submissions to FDA.

Responsibilities include, but are not limited to:
•  Active participation in ANDA/NDA project teams; provide regulatory guidance and ensure that plans and activities adhere to regulations and guidelines regarding submission. Provide project management function during the submission phase.
•  Formulate regulatory strategies for timely submissions to FDA.  Initiate and coordinate interactions as necessary with internal and external (Sponsors) members of functional groups within project teams to ensure communication of regulatory requirements and strategies relating to assigned projects.
•  Lead the coordination, preparation, and submission of all sections of ANDAs (CMC, Labeling, and Clinical (Bioequivalence), amendments and supplements to the applications to comply with the company’s strategies and timelines.
•  Oversee the electronic compilation of ANDAs in the e-CTD format for the highest quality and compliance with FDA guidance.
•  Interact with FDA Project Managers and Reviewers as necessary to obtain guidance on regulatory issues
•  Critically review and approve documents for new ANDA products and marketed products.
•  Review and approve the Annual Reports and e-processing activities prior to submission to FDA. 
•  Provide timely updates on project assignments. 
•  Monitor regulatory environment for emerging trends, new guidances and new developments which impact the generic business
•  Participate in the development of regulatory procedures that are consistent with the company’s strategy and timelines.

Requirements
BS degree with at least 4 years of Regulatory Affairs experience (ANDA filing experience preferred), with excellent writing and communication skills.