Regulatory Affairs Associate I_34318

K3-Innovations, Inc.; Illinois; Hybrid; USD 50,000 - 70,000; Full time

Job summary

K3-Innovations, Inc. is seeking a Regulatory Affairs Associate I to support regulatory information management activities at their Lake County, IL location. This hybrid role is an excellent opportunity for recent graduates with a background in pharmacy or life sciences, offering valuable exposure to global regulatory operations and compliance.

The position involves collaboration across teams to ensure the accuracy of regulatory submissions and data management. Candidates should possess excellent communication skills, attention to detail, and a strong interest in regulatory affairs.

Qualifications

• Recent graduate or early-career professional with pharmacy or health sciences background.
• Strong interest in Regulatory Affairs or Regulatory Information Management.

Responsibilities

• Support regulatory information management processes.
• Ensure accuracy and compliance of regulatory data.
• Support tracking of regulatory submissions and correspondence activities.
• Partner with stakeholders to maintain data consistency and integrity.

Skills

Excellent verbal and written communication skills

Strong attention to detail

Organizational abilities

Strong analytical skills

Proficiency with Microsoft Office applications

Education

Bachelor's Degree in Pharmacy, Biology, Pharmacology, Medical Technology, or related Life Sciences

Job description

Regulatory Affairs Associate I (Contract) – Hybrid | Lake County, IL

Are you looking to launch or grow your career in Regulatory Affairs with a global pharmaceutical organization? We are seeking a Regulatory Affairs Associate I to support regulatory information management activities, regulatory submissions tracking, compliance documentation, and data integrity initiatives across global regulatory systems.

This is an excellent opportunity for recent graduates with a pharmacy or life sciences background who are interested in developing expertise in regulatory operations, submission management, and pharmaceutical product lifecycle management.

Key Responsibilities

As a Regulatory Affairs Associate I, you will support regulatory information management processes and help ensure the accuracy, completeness, and compliance of regulatory data across multiple systems.

Regulatory Information Management Support

• Support regulatory information management activities utilizing key systems including COSMOS, HUBBLE, and CIU.
• Collaborate with central data management teams to ensure adherence to established data standards.
• Create and maintain market‑specific Regulatory Information Management (RIM) objects.
• Update product registrations to reflect approvals, renewals, new indications, packaging changes, and validity date extensions.
• Record and maintain regulatory commitments and obligations.

Regulatory Submission Tracking & Compliance

• Support tracking of regulatory submissions and correspondence activities across multiple regions.
• Ensure submission and approval dates are accurately recorded in COSMOS.
• Monitor submission archiving activities through CIU.
• Update activity statuses and maintain accurate lifecycle records.
• Verify regulatory correspondence and approval documentation are properly linked and documented.

Data Quality & Reporting

• Partner with regional and global stakeholders to maintain data consistency and integrity.
• Support monthly quality control reporting activities and assist with data remediation efforts.
• Participate in audit and inspection support activities related to submissions, approvals, commitments, and correspondence records.
• Assist in developing regional KPI and analytics requirements within HUBBLE.
• Support adoption of system enhancements, upgrades, and process improvements.

Cross-Functional Collaboration

• Work closely with regulatory teams, data management teams, analytics groups, and regional stakeholders.
• Help bridge local regulatory processes with global regulatory information management frameworks.
• Support data migration, harmonization, and continuous improvement initiatives.

Required Qualifications

Education

• Bachelor's Degree in:
• Pharmacy
• Biology
• Pharmacology
• Medical Technology
• Other related Life Sciences disciplines

Experience

• Recent graduate or early‑career professional with a pharmacy or health sciences background.
• Strong interest in Regulatory Affairs, Regulatory Operations, or Regulatory Information Management.

Skills

• Excellent verbal and written communication skills.
• Strong attention to detail and organizational abilities.
• Ability to manage multiple priorities and meet deadlines.
• Strong analytical and problem‑solving skills.Ability to work effectively in a collaborative, cross‑functional environment.
• Proficiency with Microsoft Office applications.

Preferred Qualifications

• Internship, co‑op, or academic experience in pharmaceutical, biotech, healthcare, or regulatory environments.
• Exposure to regulatory processes, compliance documentation, or pharmaceutical product registrations.
• Experience working with databases or information management systems is a plus.

Why Apply?

This opportunity provides valuable exposure to:

• Global Regulatory Affairs operations
• Regulatory Information Management (RIM) systems
• Pharmaceutical product registration processes
• Regulatory compliance and data governance
• Cross‑functional collaboration with global teams

If you're a motivated life sciences professional looking to begin a career in Regulatory Affairs with a leading pharmaceutical organization, we'd love to hear from you.