POSITION TITLE Senior Regulatory Affairs
COMPANY OVERVIEW
One of our clients- Global Pharmaceutical company located in Elk Grove Village IL is looking for Sr Regulatory Affairs specialist.
RESPONSIBILITIES
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
QUALIFICATIONS
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
WORKING TYPE Hybrid work (three days per week in the office)
WORK HOURS Monday–Friday, 9:00 AM–6:00 PM
SALARY USD90,000-110,000
BENEFITS Medical, dental vision, 401K and others
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