What are the responsibilities and job description for the Manager II, Medical Legal Regulatory Review position at Tarsus Pharmaceuticals?
About the Role
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.
Let's talk about some of the key responsibilities of the role :
- Review / approve promotional, corporate, and other non-promotional materials to assess for compliance with the applicable regulations, guidance documents, and internal policies / best
- 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. Represent the promotional regulatory perspective with cross-functional partners from Commercial, Medical Affairs, and Business Conduct (US Legal).
- 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
- Track all 2253 submissions and health authority activity to aid in resource planning for R&D
- Manage and draft responses to Health Authorities' queries. Provide support at labeling-related negotiation meetings or teleconferences.
Factors for Success :
A Few Other Details Worth Mentioning :
At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $107,200 - $150,200 plus bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being. We believe in work-life balance and offer generous paid time off, including vacation, holidays, and personal days. For more details regarding Tarsus benefits, please visit : https : / / alliantbenefits.cld.bz / 25tarsusbenesnap.
LI-Remote
LI-Hybrid
Tarsus Pharmaceuticals, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
Salary : $107,200 - $150,200
