Manager II, Medical Legal Regulatory Review

Summary

Join our team as a Mgr II, Medical Legal Regulatory Review to manage labeling, advertising and promotional review and activities associated with it for Tarsus. The role involves reviewing/approving promotional materials, managing regulatory processes, representing the company on committees, and providing support at 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 on MLR/PRC committee
• Broad knowledge of the pharmaceutical industry is preferred
• Detail-oriented with the ability to promptly assess documents for accuracy as well as interpret regulations, guidelines, and policy statements
• Strong interpersonal skills with the ability to influence others in a positive and effective manner
• Ability to work in a team
• Demonstrated ability to contribute to a continuous learning and process improvement

Responsibilities

• Review/approve promotional, corporate, and other non-promotional materials to assess for compliance with applicable regulations, guidance documents, and internal policies/best practices
• Manage and help develop a regulatory labeling, advertising, and promotion function, including processes and systems
• Represent regulatory on the Medical, Legal, and Regulatory review committee
• Serve as the Regulatory point of contact for the regulatory promotional perspective and rationale at regulatory project team meetings, labeling meetings, brand team meetings, as needed
• Review and interpret enforcement letters, keep current with industry changes relating to advertising and promotion, and interpret new guidance to the team
• Track all 2253 submissions and health authority activity to aid in resource planning for R&D
• Manage and draft responses to Health Authorities' queries

Benefits

• Health, dental and vision insurance benefits
• Generous paid time off, including vacation, holidays, and personal days