Regulatory Publishing & Submission Management
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.