Manager I, Regulatory Affairs Operations

Summary

Join Tarsus Pharmaceuticals as a Manager I, Regulatory Affairs Operations, reporting to the Director. You will assist in managing regulatory submissions and Veeva Vault RIM activities. Key responsibilities include creating and maintaining content plans, managing submissions and correspondence, drafting responses to Health Authorities, supporting project management, and coordinating with vendors. The role requires a Bachelor's degree, 5+ years of experience in Regulatory Affairs Operations, and proficiency in eCTD and Veeva RIMS. Preferred qualifications include Veeva RIMS administrator experience and expertise with various project management tools. The position offers a hybrid work environment, competitive base pay, bonus, stock equity, and comprehensive benefits including health, dental, vision, and generous paid time off.

Requirements

• Bachelor’s degree in science or health-related discipline or equivalent experience
• 5+ years of Regulatory Affairs Operations Experience, with a focus on publishing and/or submissions management, records management
• In-depth understanding of regulatory requirements and guidelines including FDA regulations, EMA guidelines and ICH standards
• Experience working with Veeva Regulatory Information Management System Vault is required; administrator experience/management of Veeva RIMS is a plus
• Experience in interpreting regulations, guidelines, and policy statements, including comprehensive knowledge of applicable regulations with demonstrated expertise relevant to RA operational activities
• Demonstrated ability to contribute to a continuous learning and process improvement
• Strong analytical skills, good attention to detail
• Ability to work concurrently on projects, each with specific instructions that may differ from project to project. Ability to work independently as needed with minimal supervision

Responsibilities

• Create and Maintain Content Plans within Veeva Vault RIM (or via Excel), understanding of eCTD Hierarchy/Modules and content planning
• Assist with planning, managing, archiving of submissions/regulatory authority correspondence, Ad & Promo submissions, dossier lifecycle management. Maintain compliance to regulatory requirements for annual reporting, etc
• Manage and draft responses to Health Authorities' queries
• Support RA submissions team/s with project management activities, tasks and tracking
• Assist with coordination and communication of regulatory submissions with external Publishing vendors
• Ability to work with firm deadlines and adapt quickly to changing requirements and priorities
• Assist in Reg Ops team management and help to develop fully functional regulatory operations team, including processes and systems
• Excellent organization, written/verbal communication and attention to detail
• Maintenance of individual training records and completion of all designated required training

Preferred Qualifications

• EDMS & Submission Technology: Proficiency in electronic submission tools and software, such as eCTD and regulatory information management systems (proficiency in Veeva RIMS is a plus). In addition, proficiency working with eCTD templates (e.g., eCTD StartingPoint® Templates, etc.). Preferred technology: Veeva Vault RIM, Content Planning, eCTD Viewers, DXC (ISI) Toolbox
• Project Management Technology: Experience and proficiency with project management tools and software such as Microsoft Word, Project, Excel, etc

Benefits

• Hybrid work environment; remote work may be considered
• The expected base pay range for this position is $93,700 - $131,300 plus bonus, stock equity, and comprehensive benefits
• Health, dental and vision insurance benefits
• Generous paid time off, including vacation, holidays, and personal days