Regulatory Affairs Associate at AbbVie USA
AbbVie is hiring a Regulatory Affairs Associate to join its global team in North Chicago, USA. This role offers a unique opportunity for professionals seeking impactful life science jobs, working on regulatory submissions, agency communications, and cross-functional collaborations. Ideal for early-career professionals, this position represents a job opportunity for life science students looking to gain international exposure and hands-on experience in pharmaceutical regulatory affairs.
About AbbVie
AbbVie is a global biopharmaceutical leader focused on innovative medicines for immunology, oncology, neuroscience, and eye care. With a commitment to research, collaboration, and patient outcomes, jobs at AbbVie offer exposure to international regulatory standards, cross-functional teamwork, and opportunities for career advancement in life science jobs.
Job Details:
- Job Title: Regulatory Affairs Associate – Global Submission Support
- Location: North Chicago, IL
- Function: Research & Development
- Employment Type: Full-time
- Job ID: R00138442
Role Overview
The Regulatory Affairs Associate, Global Submission Support, combines regulatory, scientific, and business knowledge to manage regulatory submissions, agency responses, and internal queries for AbbVie’s global product portfolio. This individual is recognized as highly knowledgeable in regulatory affairs support for emerging markets.
The role includes managing the end-to-end process for obtaining legalized documents and regulatory samples, maintaining data in internal systems, coordinating with cross-functional teams, and communicating with external organizations and vendors.
Key Responsibilities
- Serve as primary contact with Affiliate Regulatory teams for country-specific document and sample requests to support new and existing product registrations
- Assemble and submit documents to Health Authorities, embassies, and consulates, including Certificates of Pharmaceutical Products (CPPs) and Certificates of Foreign Government (CFGs)
- Collaborate with internal teams and Third-Party Manufacturers (TPMs) to obtain GMP Certificates and Manufacturing Licenses
- Coordinate with external vendors for document legalization per country requirements
- Manage end-to-end regulatory sample procurement in compliance with procedures, partnering with R&D and Global Operations
- Maintain accurate tracking of submissions, generate reports/dashboards, and provide updates to stakeholders
- Manage multiple concurrent requests, anticipate obstacles, and propose solutions
- Participate in continuous improvement initiatives for business processes, systems, and departmental standards
- Build and maintain collaborative relationships internally and externally, influencing stakeholders without formal authority
- Independently manage projects, provide progress updates, and assist with onboarding or training of new staff
Education Requirement for Regulatory Affairs Associate
- Bachelor’s degree in Life Sciences (required)
Experience:
- 2 years of pharmaceutical or industry-related experience (required)
- 2 years in Regulatory Affairs with an understanding of global regulations (preferred)
- Experience working in a complex, matrixed environment
- Demonstrated ability to work effectively with cross-functional, cross-divisional, and global teams
- Awareness of changes in global regulatory requirements and the ability to communicate impacts
- Proficiency with Microsoft Office Suite (Excel, Word, PowerPoint, Outlook) and SharePoint
Additional Notes:
Higher education may compensate for years of experience, and vice versa
Additional Information about the Regulatory Affairs Associate Job
- Compensation range will depend on location, experience, and other factors
- Eligible to participate in short-term incentive programs
- Comprehensive benefits package includes:
- Paid time off (vacation, holidays, sick leave)
- Medical, dental, and vision insurance
- 401(k) plan and other employee benefits
