Job Description

JOB DESCRIPTION:At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. Thatxe2x80x99s why wexe2x80x99re 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. Wexe2x80x99re 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. xefx82xb7 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 experience
• Preferably in the pharmaceutical and/or Health or medical device industry.
• Knowledge & experience in diabetes will be advantageous.
• An excellent communicator, both verbally & in writing.

The base pay for this position is N/AIn specific locations, the pay range may vary from the range posted.JOB FAMILY: Regulatory OperationsDIVISION: ADC Diabetes CareLOCATION: Singapore
Singapore : DUO TowerADDITIONAL LOCATIONS:WORK SHIFT: StandardTRAVEL: Yes, 10 % of the TimeMEDICAL SURVEILLANCE: Not ApplicableSIGNIFICANT WORK ACTIVITIES: Not Applicable

Abbott