Regulatory Affairs Associate II

Regulatory Affairs Associate II#26-08463

North Chicago, IL

All On-site

Job Description

Hybrid schedule - Lake County - (Onsite Tuesday, Wednesday, Thursday)

1 year to start

Preferred Education:

Batchelor'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.

Major 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.

Required 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

Preferred Experience:

Experience in Regulatory Affairs and/or Project Management preferred but may consider related area

Understanding of global regulations

MS Project experience preferred

Interviews: 1 initial screen followed by panel interview for those moving to second round

Experience Level = 2 + years

EEO:

Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.