1+ months
2018-06-012018-08-19

Project Manager Regulatory Affairs

Abbott
Princeton, NJ

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

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, 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.

Education Level

Major/Field of Study Or Education Level

Associates Degree (± 13 years)

Experience/Background

Experience Details

Minimum 7 years


Job Family: Regulatory Operations
Division: APOC Point of Care
Travel: Yes, 10 % of the Time
Medical Surveillance: No
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Categories

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Project Manager Regulatory Affairs

Abbott
Princeton, NJ

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast