Regulatory Labeling 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;

Follows Global Labeling procedures and maintains relevant databases and document management systems for assigned products.

Manages compounds with a high degree of complexity from a labeling perspective.

Works with customer experience, packaging engineering, and branding, HF, and artwork center to create layout templates for use in HF studies.

5+ years of experience in global and/or local regulatory labeling within the pharmaceutical industry.

Competent knowledge of and demonstrated ability to apply regulatory guidelines pertaining to product labeling and ICH guidelines.

Competitive salary, bonus, and generous equity offerings (RSU’s at time of offer and annual awards) – we are partners in prosperity!

Knowledge of Agile Software Document Management Solution.

Good analytical and problem-solving skills

Strong written and oral communication skills

Working on Service manuals, IFUs, knowledge of medical symbols

Basic knowledge of QSR/GMP (preferred).

Basic experience w/ print publishing, design, or document control programs.

Knowledge of global regulatory requirements

Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.

Responsible for regulatory compliance with pre- and post-approval filings and reporting requirements

Minimum 10+ years’ regulatory strategy background with experience in the MDS, AML, or MM space

Preferences include recent successful NDA experience, as well as experience within a matrix environment

Demonstrate strong organizational skills, including the ability to prioritize personal and direct reports workload.

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.