Regulatory Affairs Project Manager

Regulatory Affairs Associate II
(Project Management Focus)
Hybrid – North Chicago, IL (Onsite Tue–Thu)
Contract: 12 months to start (extension based on performance & business need)
Pay: $36–$40/hr (benefits available)
 
About the Role
Join a high-impact Regulatory Portfolio Management team supporting global regulatory strategy and execution. This role sits at the intersection of Regulatory Affairs and Project Management, driving planning, system optimization, and cross-functional collaboration to efficiently bring products to market.
You’ll work in a fast-paced, highly matrixed environment, partnering with global stakeholders to ensure regulatory plans, systems, and reporting are accurate, streamlined, and aligned with business priorities.
 
What You’ll Do

• Support and maintain regulatory planning systems (similar to MS Project/Salesforce) to ensure accurate, real-time visibility for leadership
• Partner cross-functionally (Regulatory, Clinical, Commercial, etc.) to drive planning alignment and execution
• Assist with process improvement initiatives, helping enhance tools, workflows, and reporting capabilities
• Track, update, and manage regulatory plans and large datasets, preventing backlog and ensuring data integrity
• Generate metrics, dashboards, and reports to support strategic decision-making
• Support system enhancements, including triaging requests and collaborating with internal teams
• Contribute to training materials, documentation, and system updates
• Participate in or co-lead departmental initiatives and continuous improvement efforts

 
What You Bring
Required:

• 2+ years of experience in pharma, biotech, medical device, or related industry
• Experience working in a large, matrixed organization with cross-functional teams
• Strong communication skills (written & verbal) with the ability to engage global stakeholders
• Comfortable working with project management tools and systems
• Close attention to detail with strong problem-solving abilities

Preferred:

• Experience in Regulatory Affairs, Regulatory Operations, or Project Management
• Familiarity with global regulatory environments (EU, Japan, China, etc.)
• Experience with MS Project or similar planning tools
• RAC Certification (RAPS) or PM certification is a plus

 
What Makes This Role Stand Out

• Blend of Regulatory + Project Management (ideal for candidates looking to grow in both areas)
• Exposure to global regulatory strategy and product lifecycle planning
• Opportunity to contribute to process improvements and system enhancements
• High visibility role with cross-functional and leadership interaction

 
Ideal Candidate Profile
Someone who is:

• Tech-savvy and comfortable navigating systems and large datasets
• A strong communicator and collaborator across teams
• Experienced in project coordination or regulatory environments
• Thrives in a fast-paced, structured, and global setting

 
Interview Process

• Initial screening
• Panel interview with hiring team

People are our business worldwide
 
Orion Group was founded in 1987 and is now one of the largest, independent, international recruitment companies. We have a network of 200 employees working from 24 offices, delivering a range of services – Talent Acquisition, Recruitment Outsourcing Services, Retained Search, Global Workforce Solutions, Completions & Commissioning and Materials Management – across 68 countries. As a global leader in workforce solutions, we recruit personnel across the Engineering & Technical, Office & Commercial, Scientific and Skilled Trades disciplines, for sectors including Oil & Gas, Life Science, Power & Utilities, Constructions & Infrastructure, Manufacturing and Renewables.