Manager I, Regulatory Affairs Operations

Welcome to the Tarsanet Internal Career Center!•Irvine, CA

5d•$97,500 - $136,500•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 requires creating and maintaining content plans within Veeva Vault RIM, understanding of eCTD Hierarchy/Modules and content planning. It also involves assisting with planning, managing, archiving of submissions/regulatory authority correspondence, Ad & Promo submissions, and dossier lifecycle management, while maintaining compliance to regulatory requirements for annual reporting. The position supports RA submissions teams with project management activities, tasks, and tracking, and assists with coordination and communication of regulatory submissions with external Publishing vendors. A key aspect is the ability to work with firm deadlines and adapt quickly to changing requirements and priorities. The role also involves assisting in Reg Ops team management and helping to develop a fully functional regulatory operations team, including processes and systems. Excellent organization, written/verbal communication, and attention to detail are crucial.

Requirements

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. Keywords: eCTD, NDA, IND, EU CTA, MAA, EU CTR, NDS
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

Proficiency in electronic submission tools and software, such as eCTD and regulatory information management systems (proficiency in Veeva RIMS required). 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.
Experience and proficiency with project management tools and software such as Microsoft Word, Project, Excel, etc.

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.
Maintenance of individual training records and completion of all designated required training.