Senior Regulatory Specialist Jobs in Iowa

Conduct high level proof-reading capabilities.

Maintain current knowledge of U.S. FDA submission standards.

Normal office situation or remote.

Key responsibilities for this role include:

The minimum qualifications for this role are:

Access – Providing high quality trusted medicines regardless of geography or circumstance;

Excellent project management, and critical thinking skills

Reviews domestic and/or international labeling for compliance to labeling requirements including content, format and regulatory submissions

10+ years of relevant experience

Advanced knowledge of the scientific principles of the drug development process

Advanced, broad knowledge of regulations pertaining to drug product labeling

Excellent oral and written and written communication skills

Applies regulatory and technical knowledge to a wide variety of complex work assignments.

Ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures.

Knowledge of regulations and standards affecting IVDs and/or biologics

Responsible for implementing and maintaining the effectiveness of the quality system.

Supports manufacturing/operations day to day activities for change control.

Provides consultation/advice to regulatory specialist for change control and product development.