Regulatory Operations Associate Jobs

* Due to the nature of work-related projects, this position will require US Citizenship.

* Should be able to obtain Security Clearance if required.

About Us

LexisNexis, a part of RELX, is a leading global provider of legal, regulatory, and business information. We help customers increase productivity and improve decision-making and outcomes. Our 10,500 experts and innovative tools help us shape a better world for our customers and communities.

About the Role

You will assist in the management of the development, implementation and enhancement of operating policies, processes and procedures that affect the organization's short- and long-range goals and strategies.

Responsibilities:

• Representing Reed Tech and address the client’s business requirements and needs.
• Providing Electronic Document Management System (EDMS) user support for team members.
• Managing assigned eCTD submissions through the Electronic Submissions Gateway (ESG), including troubleshooting any technical issues.
• Contributing to the authoring, review and maintenance job aids and work instructions.
• Providing input to submission timelines and track submissions in line with company procedures.
• Verifying and ensuring accuracy of all submission documents and carry out electronic publishing to current eCTD standards.
• Submission compilation, including e.g., assigning metadata, defining locations within the eCTD structure (with guidance from document authors where necessary), building XML backbone, assigning eCTD leaf titles and lifecycle operators in accordance with company procedures and FDA accepted standards.
• You will be working alongside partners, subject matter experts and industry specialists to ensure that all client deliverables meet customer expectations.
• Provide training on eCTD publishing processes and requirements related to the preparation, publishing and life-cycle management of electronic submissions.
• Monitoring eCTD submission environment and procedures, understand and communicate new/updated regulatory procedural guidelines related to electronic submissions and implement changes as required.
• Compilating and submitting of FDA submissions, including IND, NDA/sNDA and subsequent maintenance activities in the eCTD format using appropriate tools and systems.
• Conducting quality control (QC) of own submissions (content and backbone structure), both manually and using appropriate validation software in accordance with company procedures and FDA accepted standards.

Requirements:

• Committed attention to detail required.
• Experience with DocuBridge and Veeva Vault RIM preferred.
• Experience of working effectively in a global environment preferred.
• Excellent customer service skills required.
• Ability to communicate effectively (spoken and written) required.
• Knowledge of XML required.
• Excellent Word and Adobe Acrobat skills required.
• Bachelor's degree or equivalent number of years of regulatory eCTD publishing expertise.
• Experience of working effectively in a matrix environment preferred.
• Ability to work independently and under pressure (able to prioritize tasks, deadline-oriented, good organizational and problem-solving skills) required.