Senior Regulatory Operations Specialist
$49,580–$76,118 year
RemoteOntario, Canada or British Columbia, Canada
Job Summary
Senior Regulatory Operations Specialist responsible for coordinating and delivering regulatory submissions and related documentation. Key duties include building and maintaining stakeholder liaison, managing client files and submissions (eCTD, NeeS, XML Product Monographs, SPLs), validating submissions, trafficking through ESG NextGen Portal, and ensuring compliant formatting with Word, Acrobat, Excel, and PowerPoint. The role involves independent troubleshooting, back-up coordination, workflow prioritization, creating and reviewing process documentation/SOPs, assisting with marketing materials when needed, and contributing to project management with tight deadlines. Strong emphasis on confidentiality, quality control, and cross-team collaboration to support regulatory operations for Canadian and U.S. submissions, with potential training responsibilities for team members and participation in departmental meetings.
Required Qualifications
- B.Sc in life sciences
- 5-7 years of daily working experience in Regulatory Operations
- Exceptional understanding of a wide variety of submission types (Cdn and U.S.)
- Excellent written and verbal communication skills
- Advanced proficiency with Microsoft Word, Adobe Acrobat, Excel and PowerPoint
- Advanced knowledge of IT
- High knowledge of Non-eCTD electronic Submissions (NeeS)
- Complete understanding of eCTD software used at the company
- Understanding of Regulatory Operations guidelines and Regulatory Affairs guidance
- Ability to multitask and balance several projects and ad-hoc requests
- Knowledge of client confidentiality and non-crossover of project information
- Excellent project management skills and ability to meet tight deadlines
- Ability to work well independently and in a team
- Attention to detail and accuracy
- Ability to train/mentor other department members as needed
- Experience coordinating with RA and Regulatory Operations teams
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