JOB DESCRIPTION:
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 degreein 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/A
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Regulatory Operations
DIVISION:
ADC Diabetes Care
LOCATION:
Singapore > Singapore : DUO Tower
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes, 10 % of the Time
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable