Supervisor, Reg Affairs

📋 Description

• Regulatory Leadership and Team Supervision: Direct daily activities for labeling and listing
• Labeling and Packaging Approvals: Oversee and support Quality Assurance reviews and approvals for
• Claims and Package Insert Compliance: Review and approve product claims, bio-food statements, and
• Quality Investigations and Market Action Support: Collaborate with Quality Assurance managers and
• Health Hazard Evaluations: Coordinate and prepare Health Hazard Evaluations (HHEs) in collaboration
• Drug Listing and FDA Submissions: Oversee drug listing activities for pharmaceutical private-label

🎯 Requirements

• Professional Experience: Four to eight years of experience in Pharmaceutical or Medical Device
• Education: A bachelor's degree in a relevant scientific or technical discipline is preferred.
• Regulatory Knowledge: A strong understanding of pharmaceutical and medical device regulatory
• Labeling and Quality Assurance Expertise: Experience reviewing pharmaceutical labeling and
• Regulatory Systems Proficiency: Experience with regulatory and quality management platforms such as
• Drug and Device Listing Experience: Familiarity with FDA drug listing processes, UDI requirements

🎁 Benefits

• Competitive salary: Anticipated annual salary range of $79,700–$117,200, depending on geographic
• Healthcare coverage: Medical, dental, and vision insurance options to support your health and
• Retirement savings: Access to a 401(k) savings plan to help you plan for the future.
• Health savings account: HSA options to help manage eligible healthcare expenses.
• Flexible spending accounts: FSAs to support eligible healthcare and other qualified expenses.
• Paid time off: A paid time-off plan to support personal needs, rest, and work-life balance.