Position Title: Regulatory Affairs Associate
Work Location: North Chicago, IL 60064, Hybrid schedule - Lake County. (Onsite Tuesday, Wednesday, Thursday)
Assignment Duration: 12 Months (Potential Extension)
Work Arrangement: Hybrid

Position Summary: Execute assignments that ensure complete and accurate regulatory planning information is readily available for leadership and cross-functional stakeholders. Serve as a key member of the Regulatory Portfolio Management core team responsible for enhancing and maintaining the planning and reporting system(s).

Background & Context:

• May assist Enhancement Leads to triage and disposition enhancement requests. Partner with Regulatory Strategic Planning colleagues to capture large datasets and prevent backlogs.
• Update ongoing regulatory plans as necessary to align with improvements made to planning templates. Support relevant complex and/or cross-functional initiatives as needed. May lead or co-lead straightforward, departmental process improvement activities.
• May be responsible for generating regulatory planning metrics, reports, and/or other system-related needs. Assist in system-related training and/or updates to training material / logistics.

Key Responsibilities:
• Execute assignments that ensure complete and accurate regulatory planning information is readily available for leadership and cross-functional stakeholders.
• Serve as a key member of the Regulatory Portfolio Management core team responsible for enhancing and maintaining the planning and reporting system(s). May assist Enhancement Leads to triage and disposition enhancement requests.
• Partner with Regulatory Strategic Planning colleagues to capture large datasets and prevent backlogs.
• Update ongoing regulatory plans as necessary to align with improvements made to planning templates.
• Support relevant complex and/or cross-functional initiatives as needed.
• May lead or co-lead straightforward, departmental process improvement activities.
• May be responsible for generating regulatory planning metrics, reports, and/or other system-related needs.
• Assist in system-related training and/or updates to training material / logistics.

Qualification & Experience:
• 2 years of pharmaceutical or industry-related experience.
• Experience working in a complex and matrix environment.
• Strong oral and written communication skills. • Experience / understanding / use of software tools.
• Keen awareness of cultural nuances / Proven ability to work in a global environment.
• Strong attention to detail and problem-solving skills. • Experience in Regulatory Affairs and/or Project Management preferred but may consider related area.
• Understanding of global regulations.
• MS Project experience preferred.
• Bachelor’s degree.
• RAC Certification from the Regulatory Affairs Professionals Society (RAPS).

NOTE: Higher education and/or RAC certification may compensate for years of experience. Years of experience may also compensate for lower education.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 38.00/hr.