Job Title: Senior Regulatory Manager RoW Market
Department: Regulatory Affairs
Job Summary:
Key Responsibilities:
- Ensure dossiers are in line with current regulatory guidelines and client expectations.
- Regulatory Submissions & Approvals: Coordinate with agents for regulatory submission and queries.
- Track and manage timelines for submissions and approvals to ensure compliance with project milestones.
- Regulatory Intelligence & Compliance: Monitor changes in regulatory guidelines and keep relevant stakeholders informed.
- Ensure all submissions and regulatory strategies align with applicable national and international regulations.
- Lifecycle Management: Manage regulatory documentation for product variations, renewals, packaging/labelling updates, and post-approval changes.
- Audit & Documentation: Maintain and update regulatory databases and trackers.
Required Qualifications & Experience:
- Must have experience handling RoW markets.
- Strong knowledge of CTD/non-CTD formats and regulatory requirements of RoW markets.
- Experience in dealing with distributors/agents for regulatory submissions.
Key Skills:
- In-depth understanding of pharmaceutical regulatory processes.
- Strong documentation and technical writing skills.
- Ability to interpret and apply regulatory guidelines effectively.
- Excellent communication, coordination, and project management skills.
- Proficiency in MS Office and regulatory databases.
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