Manager II, Regulatory Affairs
Tarsus Pharmaceuticals, Inc.
9 hours ago
Remote friendly (Orange County, CA)
United States
Corporate Functions
Role Responsibilities:
- Assist in managing the initial workflow (Initial QC, routing, scheduling meetings) in the Veeva system for material review and approval from assigned business units.
- Review and approve promotional, corporate, and non-promotional materials for compliance with applicable regulations, guidance, and internal policies/best practices.
- Manage and help develop regulatory labeling, advertising, and promotion processes and systems.
- Represent Regulatory on the Medical, Legal, and Regulatory review committee; provide the promotional regulatory perspective with Commercial, Medical Affairs, and US Legal.
- Serve as the regulatory point of contact for promotional regulatory rationale at regulatory project team, labeling, and brand team meetings.
- Review and interpret enforcement letters; stay current on industry changes and interpret new guidance.
- Track all 2253 submissions and health authority activity for R&D resource planning.
- Manage and draft responses to health authority queries; support labeling negotiation meetings/teleconferences.
Qualifications/Requirements:
- Bachelor’s degree in science or health-related discipline.
- 8+ years relevant experience, including at least 5 years as a regulatory affairs reviewer on MLR/PRC committees. Pharmaceutical industry knowledge preferred.
Skills/Experience (Required/Preferred):
- Detail-oriented; strong document accuracy and consistency assessment.
- Strong interpersonal skills to influence others.
- Ability to work in a team environment; continuous learning and process improvement mindset.
- Regulatory expertise for promotional, corporate, and other non-promotional initiatives.
- Experience interpreting regulations/guidelines/policy statements with demonstrated labeling expertise.
- Veeva PromoMats Vault experience is a plus.
Benefits/Other:
- Hybrid role (Remote or Irvine office); travel up to 10%.
- Health, dental, and vision insurance; generous paid time off; base pay range $120,000–$168,000 plus bonus and stock equity.
Application Instructions:
- For benefits details: https://eb.alliant.com/26tarsusbenefitssnapshot.
- Assist in managing the initial workflow (Initial QC, routing, scheduling meetings) in the Veeva system for material review and approval from assigned business units.
- Review and approve promotional, corporate, and non-promotional materials for compliance with applicable regulations, guidance, and internal policies/best practices.
- Manage and help develop regulatory labeling, advertising, and promotion processes and systems.
- Represent Regulatory on the Medical, Legal, and Regulatory review committee; provide the promotional regulatory perspective with Commercial, Medical Affairs, and US Legal.
- Serve as the regulatory point of contact for promotional regulatory rationale at regulatory project team, labeling, and brand team meetings.
- Review and interpret enforcement letters; stay current on industry changes and interpret new guidance.
- Track all 2253 submissions and health authority activity for R&D resource planning.
- Manage and draft responses to health authority queries; support labeling negotiation meetings/teleconferences.
Qualifications/Requirements:
- Bachelor’s degree in science or health-related discipline.
- 8+ years relevant experience, including at least 5 years as a regulatory affairs reviewer on MLR/PRC committees. Pharmaceutical industry knowledge preferred.
Skills/Experience (Required/Preferred):
- Detail-oriented; strong document accuracy and consistency assessment.
- Strong interpersonal skills to influence others.
- Ability to work in a team environment; continuous learning and process improvement mindset.
- Regulatory expertise for promotional, corporate, and other non-promotional initiatives.
- Experience interpreting regulations/guidelines/policy statements with demonstrated labeling expertise.
- Veeva PromoMats Vault experience is a plus.
Benefits/Other:
- Hybrid role (Remote or Irvine office); travel up to 10%.
- Health, dental, and vision insurance; generous paid time off; base pay range $120,000–$168,000 plus bonus and stock equity.
Application Instructions:
- For benefits details: https://eb.alliant.com/26tarsusbenefitssnapshot.