Job Title: Regulatory Labeling Associate

Job Description

As a Regulatory Labeling Associate, you will work closely with the QA Director and the Regulatory Director to manage product labeling, prepare and submit Structured Product Labeling (SPL) files, and support the execution of Change Controls. You will also assist in project management for new and existing product labeling initiatives in line with FDA guidelines, prepare documentation for regulatory submissions, and support client inspections and audits.

ResponsibilitiesReview product labeling (bulk of the job).Prepare and submit Structured Product Labeling (SPL) files.Provide support for execution of Change Controls.Project manage new labeling initiatives for new and existing products based on FDA guidelines.Prepare documentation for FDA and client audits, depending on the time of year.Conduct research for global regulatory submissions using FDA websites.Assist in the preparation of documentation for regulatory submissions.Assist in new project planning, preparation, and execution.Support client inspections/audits.Perform data entry and documentation in Microsoft Excel and internal databases.Additional Skills & QualificationsEntry-level science graduates.Interest in regulatory labeling.About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.