- Lead end-to-end publishing activities for regulatory submissions including:
- Initial Marketing Applications
- Lifecycle Management Submissions
- Variations/Supplements
- Renewals
- Responses to Health Authority Queries
- Prepare and publish submissions in eCTD, NeeS, and regional electronic submission formats as applicable.
- Ensure submissions comply with regional Health Authority requirements and technical specifications.
- Perform technical validation using relevant validation tools and resolve publishing errors.
- Manage publishing timelines and ensure on-time delivery of submissions to Regulatory Authorities.
Team Leadership
- Lead and mentor a team of publishing specialists.
- Allocate workload and ensure optimal resource utilization.
- Conduct performance reviews, coaching, and skill development initiatives.
- Support recruitment, onboarding,
and training of current team members.
- Develop and maintain publishing standards and best practices.
Stakeholder Management
- Collaborate closely with Regulatory Affairs, Medical Writing, Labeling, CMC, Clinical, and Quality teams.
- Act as primary escalation point for publishing-related issues.
- Participate in submission strategy discussions and provide publishing guidance.
Quality & Compliance
- Ensure compliance with company SOPs, regulatory guidelines, and quality standards.
- Support audits and inspections related to submission publishing activities.
- Drive continuous process improvement and operational excellence initiatives.
- Maintain metrics and KPIs related to submission quality and turnaround times.