Manager II, Regulatory Affairs

About The Role

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

Responsibilities

• Assist in performing and managing the initial part of the workflow (Initial QC, routing, scheduling meetings, etc.) in the Veeva system for material review and approval of the materials submitted from the assigned business units
• Review/approve promotional, corporate, and other non-promotional materials to assess for compliance with the 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
• 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 Industry
• Track all 2253 submissions and health authority activity to aid in resource planning for R&D submissions
• Manage and draft responses to Health Authorities' queries
• Provide support at labeling-related negotiation meetings or teleconferences

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 consistency
• Strong interpersonal skills with the ability to influence others in a positive and effective manner
• Able to work in a team environment
• Demonstrated ability to contribute to a continuous learning and process improvement environment
• 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 labelling

Qualifications

• 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 labelling

Skills

• 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 labelling

Benefits

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 consistency. Strong interpersonal skills with the ability to influence others in a positive and effective manner. Ability to work in a team environment. Demonstrated ability to contribute to a continuous learning and process improvement environment. Under the guidance of the Sr. Director, knowledgeable resource for regulatory advice on promotional, corporate, and other non-promotional initiatives in other departmentsExperience 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 labelling

Pay

The expected base pay range for this position is $120,000 - $168,000 plus bonus, stock equity, and comprehensive benefits.

Schedule

We provide a hybrid work environment. We are passionate about our culture! Our Tarsans live our values of commitment to patients, empowerment to champion innovation, and teamwork to amplify impact!

A Few Other Details Worth Mentioning

• The position can be either Remote or based in our beautiful Irvine office, complete with onsite gym, pool, snacks, drinks, and occasional catered meals.
• 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://eb.alliant.com/26tarsusbenefitssnapshot.

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.