Role Objective:
This role focuses on strategic filing (DMF/CEP), maintaining the complete lifecycle of submissions through quality documentation, timely approvals and business continuity.

KEY RESPONSIBILITIES
Pre-approval - Prefilling Support and New DMF / CEP Fillings: Review of the various Pre-filling documents [TTD / Process / Specifications / Validations / Stability ext.] with agreed timelines. Meeting submission timelines of assigned projects for identified markets.
Pre-approval - Deficiency Responses: Review comments of the various response documents with agreed timelines with stakeholders. Meeting submission timelines of assigned projects for identified markets.
Change control, Vendor Notifications and Deviations: Review of change controls, deviations, vendor notifications and their impact assessment on the submissions.
Post Approval - DMF / CEP Amendments [Post approval changes / variations], Annual reports: Meeting submission timelines of assigned projects for identified markets and approval of the life cycle changes for business continuity.
Support to cross functional team:



Handling of Customer requests, Regulatory support / guidance to all manufacturing sites, cross functional team, Health Authority Audits, Quality agreement review.

STAKEHOLDER INTERACTION
Type of Interaction: Internal
Interaction with: R&D;, QC, QA, Manufacturing Sites, Projects management.
Nature of Interaction: Gathering technical data, document review, technical discussions for DMF / CEP filings, amendments, responses.

Type of Interaction: Internal & External
Interaction with: Cross functional team & external customers
Nature of Interaction: Submission of dossiers, defending technical queries, and notifying stakeholders of regulatory changes.

JOB REQUIREMENTS
Skilled Experience and Relevant Skills
4–7 years of hands-on experience in Regulatory Affairs.
Domain Expertise: Proven experience in filing Drug Master Files (DMF) and Certificates of Suitability (CEP).
Regulatory Knowle

📌 Senior Executive (Govandi East)
🏢 USV
📍 Govandi East