Regulatory Affairs Associate

Position Title: Regulatory Affairs Associate

Work Location: North Chicago, IL 60064, Hybrid schedule - Lake County. (Onsite Tuesday, Wednesday, Thursday)

Assignment Duration: 12 Months

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.