Regulatory Affairs Associate

Teklysium Inc • Chicago, IL

1d • Hybrid

About The Position

This role is for a Regulatory Affairs Associate with a hybrid schedule, requiring onsite presence Tuesday, Wednesday, and Thursday in Lake County. The initial contract is for 1 year. The manager is seeking candidates with strong project management skills, experience working with various teams and regulatory agencies, and a background in process improvement and change management within a regulatory system. Experience in pharma or medical device industries is suitable. Strong communication skills and industry experience are essential. Regulatory experience, including international experience (Europe, China, or India), is also valued. The position requires a Bachelor's degree, with RAC Certification from the Regulatory Affairs Professionals Society (RAPS) preferred. Higher education or RAC certification can compensate for years of experience, and vice versa.

Requirements

• 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
• Batchelor’s degree

Nice To Haves

• Project management
• Experience with the regulatory system and Change management
• PMP is preferred
• Pharma or medical device experience
• Veeva, Salesforce is great to have
• Microsoft Office experience
• International experience (Europe, China, or India)
• RAC Certification from the Regulatory Affairs Professionals Society (RAPS)
• Experience in Regulatory Affairs and/or Project Management preferred but may consider related area
• Understanding of global regulations
• MS Project experience preferred

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1-10 employees