Abbott - Manager - Regulatory Affairs - ADC

MAIN PURPOSE OF ROLE:

- Specialist professional individual contributor with comprehensive knowledge in the area of Regulatory Affairs.

- Ability to execute highly complex or specialized projects.

- Adapts precedent and may make significant departures from traditional approaches to develop solutions.

Main Responsibilities:

- As the Specialist in the Regulatory Affairs Sub-Function, considered as highly experienced and knowledgeable resource within the organization 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.

Experience/Background: Minimum 7 years.