What are the responsibilities and job description for the Regulatory Affairs Manager position at Experis?
Our client, a regulated pharmaceutical organization is seeking a Regulatory Affairs Manager to join their team. As a Regulatory Affairs Manager, you will be part of Global Regulatory Affairs (GRA) supporting Global Labeling Operations and cross-functional safety labeling governance. The ideal candidate will have a strong commitment to patient safety, the ability to manage complex regulatory processes across global markets, and the drive to continuously improve labeling quality through data-driven KPI reporting.
Job Title: Regulatory Affairs Manager
Location: Deerfield, IL (HYBRID: onsite 3 days a week)
Duration: 12 months with the possibility of extension/conversion
Pay Range: $44/hr w2
What's the Job?
About ManpowerGroup, Parent Company of: Manpower, Experis, Talent Solutions, and Jefferson Wells.
ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands – Manpower, Experis, Talent Solutions, and Jefferson Wells – creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2023 ManpowerGroup was named one of the World's Most Ethical Companies for the 14th year - all confirming our position as the brand of choice for in-demand talent.
Job Title: Regulatory Affairs Manager
Location: Deerfield, IL (HYBRID: onsite 3 days a week)
Duration: 12 months with the possibility of extension/conversion
Pay Range: $44/hr w2
What's the Job?
- Provide strategic oversight of safety-related labeling variations that impact regulated pharmaceutical drug products while ensuring regulatory compliance and consistent communication of product information across global markets.
- Serve as the key interface between Pharmacovigilance (PV), the Regulatory Affairs Labeling Team, and Global Labeling Operations to ensure safety labeling processes are owned, established, and executed effectively.
- Own and drive safety labeling processes for GRA, including CCDS and associated Safety Variations, generic labeling and monitoring of innovator labels, and monitoring of PRAC and MOH triggers.
- Oversee generic labeling surveillance and innovator-label monitoring, including oversight of PRAC recommendations and coordination of NCRs.
- Lead continuous improvement through CCDS metrics and KPI reporting, and provide safety labeling governance by escalating risks associated with overdue safety variations.
- Bachelor’s degree (or country equivalent) in a scientific discipline; a Master’s and/or PhD is an advantage.
- Minimum of 5 years of regulatory experience in Regulatory Affairs (RA) or a related field, including experience managing people or projects.
- Strong scientific knowledge and the ability to multitask and prioritize in a fast-moving, compliance-focused environment.
- Ability to work effectively in a multinational/multicultural environment and collaborate across matrix teams.
- Demonstrated regulatory knowledge, management skills, and strong interpersonal, communication, and presentation abilities, including the ability to identify compliance risks independently and escalate when necessary.
- Opportunity to directly influence patient safety through safety labeling governance and consistent global product information.
- Ownership of critical systems and processes, including serving as System Owner for Fluxguard and CCDS/Safety Labeling Tracking.
- Visibility and impact across cross-functional teams, including support for PV and RA inspections related to safety labeling.
- Chance to strengthen the safety variation submission process by developing training materials and supporting related system changes.
- A role built for continuous improvement, where you can lead KPI reporting, drive process enhancements, and elevate compliance outcomes.
- Medical and Prescription Drug Plans
- Dental Plan
- Vision Plan
- 401(k), Plus Match
- Weekly Pay
About ManpowerGroup, Parent Company of: Manpower, Experis, Talent Solutions, and Jefferson Wells.
ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands – Manpower, Experis, Talent Solutions, and Jefferson Wells – creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2023 ManpowerGroup was named one of the World's Most Ethical Companies for the 14th year - all confirming our position as the brand of choice for in-demand talent.
Salary : $44