Regulatory Associate

Job Title: Regulatory Associate

Job Description

As a Regulatory Documentation Associate, you will be responsible for organizing compliance documents to support regulatory activities, ensuring federal and state compliance related to the storage, sale, and distribution of FDA-regulated pharmaceuticals. You will work under direct supervision to manage and disseminate important documentation and assist in product releases using regulatory software.

Responsibilities

• Communicate with different vendors to request packing slips and disseminate documents to the appropriate team members.
• Perform product releases using regulatory software.
• Collaborate with internal and external stakeholders to manage DSCSA-related activities, including customer account setup and retrieval of electronic data for authorized trading partners.
• Provide portal navigation training for customers and respond to trading partner requests for login credentials.
• Manage compliance documents by reviewing for completeness, sorting, extracting files from bulk PDFs, renaming documents, and filing.
• Conduct quality checks on documents before saving and titling them for other team members.

Essential Skills

• Strong written and verbal communication skills
• Proficiency in quality assurance, PDF editing, Microsoft Office, and Adobe
• Regulatory compliance knowledge
• Computer skills in science and medical devices
• Attention to detail and a sense of urgency

Additional Skills & Qualifications

• Degree in Science or an Associate's Degree
• Experience with Excel, documentation, or filing
• Ability to manage time effectively and shift priorities when needed

Work Environment

This position is based at the Northfield Regulatory Office with a hybrid work model, allowing for mostly remote work after a four-week onsite training period. The team operates on the 1st shift with a start time between 8 or 9 am and a finish time between 4 or 5 pm. The role offers a chance to build a career in regulatory documentation, with potential opportunities for project extensions and advancement within the team.

Job Type & Location

This is a Contract position based out of Northfield, IL.

Pay and Benefits

The pay range for this position is $22.00 - $25.00/hr.

Eligibility requirements apply to some benefits and may depend on your job
classification and length of employment. Benefits are subject to change and may be
subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a hybrid position in Northfield,IL.

Application Deadline

This position is anticipated to close on Nov 3, 2025.

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.

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 due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.