At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. That’s why we’re focused on helping people with diabetes manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.

Job Purpose:

Manages teams within the Regulatory Affairs Sub-Function. Focus is on policy and strategy implementation and control rather than development. Typically handles short-term operational/tactical responsibilities.

Responsibilities

As the Manager of the Regulatory Affairs Sub-Function, oversees the strategy implementation and operations for 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, local submission package/chemistry manufacturing control (CMC) preparation.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.

Requirements

A bachelor's degree in a related field Min 7 years of experiencePreferably in the pharmaceutical and/or Health or medical device industry.Knowledge & experience in diabetes will be advantageous.An excellent communicator, both verbally & in writing.