Regional Regulatory Affairs Manager

Regional Regulatory Affairs Manager

Apply locations Singapore time type Full time posted on Posted 2 Days Ago job requisition id 31105192

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

1. 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.
2. Interacts with regulatory agency to expedite approval of pending registration. Serves as regulatory liaison throughout product lifecycle.
3. Participates in some of the following: product plan development and implementation, regulatory strategy, risk management, local submission package/chemistry manufacturing control (CMC) preparation.
4. Ensures timely approval of new drugs, biologics or medical devices and continued approval of marketed products.
5. Serves as regulatory representative to marketing, research teams and regulatory agencies.
6. Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.

Requirements

1. A bachelor's degree in a related field
2. Min 7 years of experience
3. Preferably in the pharmaceutical and/or Health or medical device industry.
4. Knowledge & experience in diabetes will be advantageous.
5. 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

About Us

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.

We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.