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.