MAIN PURPOSE OF ROLE

Entry para-professional individual contributor representing the most common entry point for this career stream.

Works under direct supervision within the Regulatory Affairs sub-function.

MAIN RESPONSIBILITIES

•As the Entry para-professional in the Regulatory Affairs Sub-Function, possesses basic knowledge in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.

•Interacts with regulatory agency to expedite approval of pending registration.

•Serves as regulatory liaison throughout product lifecycle.

•Participates in some of the following: product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC).

•Ensures timely approval of new drugs, biologics or medical devices and continued approval of marketed products.

•Serves as regulatory representative to marketing, research teams and regulatory agencies.

•Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.

QUALIFICATIONS

Education

High School Diploma / GED