Senior Regulatory Associate

• Be responsible for publishing, dispatching, and archiving Regulatory Submissions in agency recommended formats

• Be responsible for supporting regulatory audits and related compliance activities

• Ensure the timely delivery of high-quality Regulatory Submissions following client and internal processes.

• Prepare submission ready documents for electronic submissions including formatting, hyperlinking, and processing MS Word and Adobe Acrobat documents

• Develop and maintain up-to-date knowledge of established agency standards and procedures for Regulatory Submissions.

• Troubleshoot document issues with Adobe Acrobat and MS Word

• Manage technical aspects for assigned submissions and status updates

• Collaborate with various departments for the planning, preparation, publishing, and quality control checks of submissions.

• Have prior experience and knowledge of various Publishing and Validation tools

• Train and mentor junior staff members.

• Assist in revisions of department SOPs, Work Instructions, and training materials

• Experience in Publishing and Submissions is required

Bachelor s Degree in Pharma