Job Title: Regulatory Associate
Job Description

Under direct supervision, the Regulatory Associate is responsible for organizing compliance documents to aid in the planning and execution of regulatory activities, ensuring federal and state compliance related to the storage, sale, and distribution of FDA-regulated pharmaceuticals. The role requires excellent organizational skills and the ability to communicate effectively with different vendors.

ResponsibilitiesCommunicate with vendors to request packing slips and disseminate documents to the appropriate team members.Perform product releases using regulatory software.Verify and release compliant products using regulatory and warehouse management software.Manage compliance documents by reviewing for completeness, sorting, extracting files from bulk PDFs, renaming, and filing.Quality check documents for completeness before saving and passing them along to other team members for review.Carry out mini projects such as master data updates, repetitive tasks in software systems to formally release products, and manual product releases from warehouse management systems.Essential SkillsQuality assuranceProficiency in PDF and Microsoft OfficeExperience with Adobe Acrobat and Adobe InDesignKnowledge of GMP, FDA regulations, and regulatory complianceStrong computer skillsExperience in document control and regulatory documentationAdditional Skills & QualificationsBachelor's degree in Science (4-year degree)At least 1 year of industry-related experience in Sciences and 1 year of computer experience in a professional environmentExperience with Excel and documentation or filingAdobe experience and editing PDF experiencePreference for candidates with recent on-site work experienceWork Environment

The Regulatory Associate will work in a hybrid environment, starting with one month of on-site training at the Northfield Regulatory Office. After training, the role transitions to mostly remote work, 4-5 days a week. The team is responsible for Drug Securities Act Regulatory work, with critical deadlines to meet in order to account for all pharmaceutical products from different warehouses in internal computer systems.

Pay and Benefits

The pay range for this position is $20.00 - $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 Mar 7, 2025.

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.