Manager I, Regulatory Affairs Operations
Tarsus Pharmaceuticals, Inc.
August 22, 2026
Remote friendly (Orange County, CA)
United States
Operations
Responsibilities:
- Create and maintain content plans within Veeva Vault RIM, understanding eCTD hierarchy/modules and content planning.
- Plan, manage, and archive submissions and regulatory authority correspondence, including Ad & Promo submissions; manage dossier lifecycle and maintain compliance for annual reporting.
- Support Regulatory Affairs (RA) submissions teams with project management activities, tasks, and tracking.
- Coordinate and communicate regulatory submissions with external publishing vendors.
- Work with firm deadlines and adapt quickly to changing requirements and priorities.
- Assist with Reg Ops team management and development, including processes and systems.
- Maintain excellent organization, communication (written/verbal), and attention to detail.
Skills/Technology:
- Proficiency with electronic submission tools (eCTD, regulatory information management systems); Veeva RIMS proficiency required.
- Experience with eCTD templates (e.g., eCTD StartingPoint Templates).
- Preferred: Veeva Vault RIM, content planning, eCTD viewers, DXC (ISI) Toolbox.
- Project management tools: Microsoft Word, Project, Excel (or similar).
- Maintain individual training records and complete required training.
Qualifications/Requirements (Factors for Success):
- Bachelor’s degree in science/health-related field or equivalent experience.
- 5+ years Regulatory Affairs Operations experience focused on publishing/submissions management and records management.
- In-depth understanding of FDA, EMA, and ICH standards; familiarity with eCTD, NDA/IND, EU CTA/MAA/EU CTR/NDS.
- Experience administering/managing Veeva RIMS (Veeva Regulatory Information Management System Vault required).
- Ability to interpret regulations/guidelines/policy and contribute to continuous learning and process improvement.
- Strong analytical skills and attention to detail; ability to work independently and manage concurrent projects.
- Demonstrated decision-making, collaboration, team-building, and outcome-driven approach.
Benefits/Other Details:
- Hybrid work environment; remote work may be considered. Position based in Irvine office; some travel up to 20%.
- Health, dental, and vision insurance; generous paid time off (vacation, holidays, personal days).
- Create and maintain content plans within Veeva Vault RIM, understanding eCTD hierarchy/modules and content planning.
- Plan, manage, and archive submissions and regulatory authority correspondence, including Ad & Promo submissions; manage dossier lifecycle and maintain compliance for annual reporting.
- Support Regulatory Affairs (RA) submissions teams with project management activities, tasks, and tracking.
- Coordinate and communicate regulatory submissions with external publishing vendors.
- Work with firm deadlines and adapt quickly to changing requirements and priorities.
- Assist with Reg Ops team management and development, including processes and systems.
- Maintain excellent organization, communication (written/verbal), and attention to detail.
Skills/Technology:
- Proficiency with electronic submission tools (eCTD, regulatory information management systems); Veeva RIMS proficiency required.
- Experience with eCTD templates (e.g., eCTD StartingPoint Templates).
- Preferred: Veeva Vault RIM, content planning, eCTD viewers, DXC (ISI) Toolbox.
- Project management tools: Microsoft Word, Project, Excel (or similar).
- Maintain individual training records and complete required training.
Qualifications/Requirements (Factors for Success):
- Bachelor’s degree in science/health-related field or equivalent experience.
- 5+ years Regulatory Affairs Operations experience focused on publishing/submissions management and records management.
- In-depth understanding of FDA, EMA, and ICH standards; familiarity with eCTD, NDA/IND, EU CTA/MAA/EU CTR/NDS.
- Experience administering/managing Veeva RIMS (Veeva Regulatory Information Management System Vault required).
- Ability to interpret regulations/guidelines/policy and contribute to continuous learning and process improvement.
- Strong analytical skills and attention to detail; ability to work independently and manage concurrent projects.
- Demonstrated decision-making, collaboration, team-building, and outcome-driven approach.
Benefits/Other Details:
- Hybrid work environment; remote work may be considered. Position based in Irvine office; some travel up to 20%.
- Health, dental, and vision insurance; generous paid time off (vacation, holidays, personal days).