We are looking for a Senior Regulatory Associate. The successful candidate will:
- 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
Desirable Skills and Experience
- Experience in Publishing and Submissions is required
Bachelor’s Degree in Pharma
18 Feb 2021