Regulatory Affairs Specialist

JOB DESCRIPTION:

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:

• •Career development with an international company where you can grow the career you dream.
• •A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• •A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Abbott Thailand location in the Core Diagnostics.We’re empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.

What You’ll Work On

• •As the Experienced professional in the Regulatory Affairs Sub-Function, possesses well developed skills 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.

Required Qualifications

• •Minimum of bachelor’s degree in sciences, Pharmacy, engineering or equivalent education/work experience will be considered.
• •2-3 years experience
• •Knowledge of local Medical Device regulations will be an advantage
• •Conversant local language as well as both written and spoken English

Apply Now

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at abbott.com , on LinkedIn at https://www.linkedin.com/company/abbott-/ , and on Facebook at https://www.facebook.com/AbbottCareers .

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:

CRLB Core Lab

LOCATION:

Thailand > Bangkok : Q-House Lumpini Building

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

No

MEDICAL SURVEILLANCE:

Yes

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)