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:

1. Stability data, Technical Transfer Documents (TTD), and Pharmaceutical Development Reports (PDR).
2. Analytical method validations.
3. BMR/ BPR, Hold time report, process validation report etc
4. 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.

1. 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