Regulatory Information Management Contractor

About the Position

Hi there, This is Siddhi, Talent Expert with Collabera LLC. Hope this message finds you well! We're hiring for Regulatory Information Management Contractor positions in North Chicago, Illinois, US. Top performers encouraged to apply as positions are filling fast! If interested, Let's connect and don't miss out. Apply today and let's talk about your next big opportunity!

Email: [email protected] | Phone: (847)-440-1112.

Job Details

• Job Title: Regulatory Information Management Contractor
• Location: North Chicago, IL 60064 / Hybrid, onsite Tues, Wed, Thurs
• Duration: 6 Months Contract (possibility of extension based on performance and business needs)
• Pay Rate: $25.00 to $30.00 Per Hour

Responsibilities

• Monitor activity in COSMOS (Regulatory Information Management solution) for assigned products and activities, ensuring completeness and accuracy of data.
• Follow agreed-upon data standards for creating RIM objects, including:
  • Create or update product, application, and registration data, including new registration, validity date period, indication, and pack.
  • Record and update commitments/obligations.
  • Monitor submission archival via CIU.
  • Move notification-only activities to completed status.
  • Monitor agency correspondence/responses imported into COSMOS and associated with relevant activities.
  • Link response structures to relevant activities.
  • Import approval letters in relation to relevant activities and update activity status and dates to reflect approval.
  • Support audit/inspection requests related to data in COSMOS.
  • Support system enhancements and data remediation activities.
  • Support migration and harmonization of data during system upgrades, process improvements, and acquisitions.

Requirements

• Must Have:

  • Entry-level associate contractor within the Regulatory Information Management (RIM) team; training will be provided on systems and processes.
  • Approximately 50% of time will be spent on day-to-day RIM administrator responsibilities and 50% on projects involving global data enhancement, remediation, and QC.
  • Monitor requests from system users requiring RIM administrator support.
  • Set up product data and create regulatory applications for system users.
  • Create and update product registration data as approvals are received.
  • Monitor and update activity statuses, submission dates, validity periods, and approval information.
  • Handle renewal-related updates when validity periods change.
  • Update product data based on product acquisitions, pipeline activity, and project plans.
  • RIM experience is preferred but not required; experience with another RIM system is acceptable.
  • Regulatory or Regulatory Operations experience, particularly 1–2 years, is preferred and can substitute for direct RIM experience.
  • Should be motivated, able to learn systems quickly, execute assigned tasks after training, manage daily responsibilities independently, understand project goals, and ask questions when needed.
  • Candidates with more experience may be considered if comfortable with the entry-level nature of the role.
  • Recent master's graduates with co-op/internship experience, as well as master's and PhD graduates, considered.
  • Comparable, experience with the team's RIM system (COSMOS) would likely be preferred.
  • Specific RIM system experience is not mandatory because appropriate training will be provided.
  • Regulatory experience is valuable because it provides familiarity with agencies and application types.

• Qualifications:

  • Bachelor's degree in related life sciences (pharmacy, biology, chemistry, medical technology, pharmacology).
  • 0–2 years of experience in pharmaceutical, medical device, or healthcare-related field.
  • Preferred: 0–2 years of experience in Regulatory Affairs or Regulatory Operations.
  • Good oral and written communication skills.

We Offer

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, paid holidays annually.

About the Company

Collabera LLC is a leading provider of talent solutions, helping organizations find and develop the right talent to drive their success. We are committed to providing exceptional service and fostering a collaborative work environment.

Apply Now

Don't miss out on this exciting opportunity. Apply now and take the next step in your career with Collabera LLC.