Manager I, Regulatory Affairs Operations

Tarsus Pharmaceuticals•Irvine, CA

4d•Hybrid

About The Position

The Manager I, Regulatory Affairs Operations will report to the Director, Regulatory Affairs Operations, and will primarily assist in managing Electronic Document Management System (Veeva Vault RIM) and regulatory submissions activities. This role involves creating and maintaining content plans, assisting with the planning, management, and archiving of submissions, maintaining compliance with regulatory requirements, supporting the RA submissions team with project management, and coordinating with external publishing vendors. The position also contributes to team management, process and system development, and requires excellent organization, communication, and attention to detail. Proficiency in electronic submission tools like eCTD and regulatory information management systems (Veeva RIMS required) is essential, as is experience with eCTD templates and project management tools. The role requires a Bachelor's degree in a science or health-related discipline or equivalent experience, with a minimum of 5 years of Regulatory Affairs Operations Experience focused on publishing, submissions management, and records management. A deep understanding of regulatory requirements (FDA, EMA, ICH) is necessary, along with experience interpreting regulations and guidelines. The role demands strong analytical skills, attention to detail, the ability to manage multiple projects concurrently, and the capacity to work independently. Key competencies include decision-making, collaboration, team building, and an outcome-driven approach. Some travel may be required.

Requirements

Proficiency in electronic submission tools and software, such as eCTD and regulatory information management systems (proficiency in Veeva RIMS required).
Proficiency working with eCTD templates (e.g., eCTD StartingPoint ® Templates, etc.).
Experience and proficiency with project management tools and software such as Microsoft Word, Project, Excel, etc.
Bachelor’s degree in science or health-related discipline or equivalent experience.
Minimum of 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.
Under the guidance of the Director, knowledgeable resource for regulatory advice in developing submission content plans, with hands-on responsibility for regulatory document management.
Experience working with Veeva Regulatory Information Management System Vault is required; administrator experience/management of Veeva RIMS is a requirement.
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.
Decision Making - Identifies, analyzes, and resolves issues or challenges effectively and efficiently. Demonstrates creativity, decisiveness, and the capacity to implement solutions in a structured and outcome-oriented manner. Navigates uncertainty when there’s not a blueprint for success. Owns their decisions and actions.
Collaboration and Team Building - Builds strong relationships and networks. Is curious about and respectful of different points of view. Cultivates a safe space for discussion readily engaging in group dialogue and debate. Puts the team first.
Outcome Driven - Clearly defines mutual expectations of self and others in a team setting. Adapts to changing business needs. Is determined and resourceful in finding solutions, even when faced with obstacles. Takes appropriate actions, including calculated risks, to ensure obligations are met.

Nice To Haves

Preferred technology: Veeva Vault RIM, Content Planning, eCTD Viewers, DXC (ISI) Toolbox.

Responsibilities

Create and Maintain Content Plans within Veeva Vault RIM, 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.
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.