Regulatory Affairs Senior Manager

Job Summary

Providing strategic direction for product and disease communications, the full-time remote Regulatory Affairs Senior Manager will ensure compliance with FDA regulations, evaluate promotional materials, and mentor team members in a dynamic regulatory environment.

Key responsibilities:

• Evaluate promotional materials and provide guidance on compliance with regulatory requirements
• Assess the impact of regulatory changes on promotional strategies and update the team accordingly
• Mentor and support the development of junior regulatory reviewers

Required qualifications:

• Doctorate degree with 2 years of related experience, or Master's degree with 4 years, or Bachelor's degree with 6 years, or Associate's degree with 10 years, or High school diploma/GED with 12 years of related experience
• Experience in evaluating promotional materials and understanding regulatory compliance
• Demonstrated ability to interpret and apply promotional regulations in a changing environment
• Proven leadership and mentoring skills
• Strong analytical judgment and negotiation skills