Sr Regulatory Affairs

Position Title

Senior Regulatory Affairs

One of our clients—a Global Pharmaceutical company located in Elk Grove Village, IL—seeks a Senior Regulatory Affairs Specialist.

• Develop regulatory submission strategies for new products
• Prepare and maintain NDA and ANDA submissions
• Serve as the primary point of contact with the U.S. FDA (CDER, CDRH, CBER, etc.)
• Draft U.S. prescription drug labeling and review translated package inserts
• Monitor regulatory changes and communicate impacts to internal stakeholders
• Collaborate with global teams to ensure compliant regulatory processes
• Manage cost estimates related to submissions and regulatory maintenance
• Support the development of the RA organizational structure and budget

• Bachelor’s degree in a relevant scientific field (advanced degrees preferred)
• Business level Japanese language skill preferred
• Minimum 5 years of experience interacting with the U.S. FDA
• Strong stakeholder management and consensus-building skills
• Excellent verbal and written communication skills in English
• Ability to lead productive meetings, both virtual and in person
• Adaptable, hands‑on, startup‑minded approach
• High level of integrity, professionalism, and discretion
• Strong analytical, problem‑solving, and interpersonal skills
• Resilience and persistence in overcoming challenges

Hybrid work (three days per week in the office)

Monday – Friday, 9:00 AM–6:00 PM

USD 90,000–110,000

Medical, dental, vision, 401K, and others