MAIN PURPOSE OF ROLE

Experienced professional individual contributor that works under limited supervision.

Applies subject matter knowledge in the area of Regulatory Affairs.

Requires capacity to apply skills/knowledge within the context of specific needs or requirements.

MAIN RESPONSIBILITIES

•As the Experienced professional in the Regulatory Affairs Sub-Function, possesses well developed skills 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

Associates Degree (± 13 years)