Mgr II, Medical Legal Regulatory Review - Remote

Overview

The Mgr II, Medical Legal Regulatory Review will report to the Sr. Director, Regulatory Affairs, and will manage the labeling, advertising and promotional review and activities associated with it for Tarsus.

In Short

• Review/approve promotional, corporate, and other non-promotional materials for compliance.
• Manage and develop a regulatory labeling, advertising, and promotion function.
• Represent regulatory on the Medical, Legal, and Regulatory review committee.
• Serve as the Regulatory point of contact for promotional perspective.
• Review and interpret enforcement letters and industry changes.
• Track all 2253 submissions and health authority activity.
• Manage and draft responses to Health Authorities' queries.
• Support at labeling-related negotiation meetings.

Requirements

• Bachelor’s Degree in science or health-related discipline required.
• 8+ years of relevant experience, with a minimum of 5 years as a regulatory affairs reviewer.
• Detail-oriented with the ability to assess documents for accuracy.
• Strong interpersonal skills with the ability to influence others.
• Ability to work in a team.
• Demonstrated ability to contribute to continuous learning and process improvement.
• Knowledgeable resource for regulatory advice on promotional initiatives.
• Experience with Veeva PromoMats Vault is a plus.
• Experience in interpreting regulations and guidelines.

Benefits

• Hybrid work environment with remote options.
• Comprehensive health, dental, and vision insurance.
• Generous paid time off including vacation and personal days.
• Bonus and stock equity opportunities.
• Supportive company culture focused on innovation and teamwork.