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.

SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at nahr@spectraforce.com if you require reasonable accommodation.