What are the responsibilities and job description for the Manager II, Medical Legal Regulatory Review position at Welcome to the Tarsanet Internal Career Center!?
About the Role
The Mgr II, Medical Legal Regulatory Revie 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:
- 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
- Strong interpersonal skills with the ability to influence others in a positive and effective
- Ability to work in a team
- Demonstrated ability to contribute to a continuous learning and process improvement
- Under the guidance of the Sr. Director, knowledgeable resource for regulatory advice on promotional, corporate, and other non-promotional initiatives in other departments
- Experience working with Veeva PromoMats Vault is a plus.
- Experience in interpreting regulations, guidelines, and policy statements, including comprehensive knowledge of applicable regulations with demonstrated expertise relevant to labeling.
A Few Other Details Worth Mentioning:
- The position can be either Remote or based in our beautiful Irvine office, complete with a courtyard, snacks, drinks, and occasional catered meals. We provide a hybrid work
- We are passionate about our culture! Our Tarsans live our values of commitment to patients, empowerment to champion innovation, and teamwork to amplify impact!
- This position reports directly to our Director, Regulatory Affairs
- Some travel may be required
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/tarsus2024BenSnapshot.
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