Job Description
Role Objective:
The primary objective of this role is to facilitate the timely market entry of drug products by preparing high-quality, compliant regulatory submissions. You will act as a bridge between technical departments and regulatory bodies, ensuring that all documentation aligns with current country-specific guidelines and internal quality standards.
KEY RESPONSIBILITIES
Dossier Management & Filing: Collate, prepare, and file accurate dossiers for formulations and drug products to secure licenses in targeted markets.
Documentation & Compliance: Develop comprehensive checklists for regulatory filings based on current, country-specific requirements.
Technical Review: Conduct first-level reviews of critical technical documentation, including:
Stability data, Technical Transfer Documents (TTD), and Pharmaceutical Development Reports (PDR).
Analytical method validations.
BMR/ BPR, Hold time report, process validation report etc
Specifications for API, Semi-Finished, and Finished Products.
Artwork & Labeling:



Perform initial reviews of labeling and artwork to ensure strict adherence to the regulations of the filing market.
Change Control & Impact Analysis: Analyze the regulatory impact of internal change controls and communicate necessary notifications/approvals to customers.
Evaluate vendor-notified changes against country-specific requirements.
Lifecycle Management: Assess post-approval changes and prepare necessary amendments, supplements, or annual reports to maintain continuous compliance.
e-CTD Publishing: Manage the compilation and publishing of e-CTD DMFs/Dossiers for submission to Health Authorities and customers.
Query Resolution: Assist in resolving queries from regulators or customers, assessing technical responses before escalating to the Team Leader.
Facility Registration: Prepare and e-file documents for USFDA facility registrations.

STAKEHOLDER INTERACTION
Type of Interaction: Internal
Interaction

📌 Senior Officer Govandi East
🏢 USV
📍 Govandi East