Role Objective: To lead and manage the compilation, submission, and lifecycle maintenance of high-quality regulatory registration dossiers (eCTD format) for the European market (including DCP, National, and MHRA procedures). The role ensures absolute compliance with EU regulations, timely response to health authority queries , and seamless execution of post-approval variations and change controls

KEY RESPONSIBILITIES
- Dossier Compilation & Submission: Compile and submit high-quality registration dossiers in eCTD format in strict accordance with current EU & ICH guidelines for DCP, National procedures, and MHRA submissions.
- Query Management: Thoroughly assess and draft technically sound, timely responses to queries raised by European regulatory agencies within agreed-upon timelines.
- Lifecycle Management & Variations: Manage the post-approval lifecycle of products, compiling variation packages and executing changes in licenses via variations and notifications.
- Portal & Tool Management:



End-to-end handling of electronic submissions via the EU/MHRA Portal using eCTD software tools.
- Technical Documentation Review: Coordinate, collate, and perform high-quality reviews of standard technical documents including specifications, stability data, Product Development Reports (PDR), method validations, sterility assurance packages, BMR, and BPR to ensure ICH/EU alignment.
- Compliance Maintenance: Review and handle change control proposals, assessing their regulatory impact and implementation strategy. Maintain a basic working knowledge of European Medical Device Regulations and Pharmacovigilance requirements.

STAKEHOLDER INTERACTION

Type of Interaction: Internal
- Interaction with: Cross-functional teams including R&D;, Quality Assurance (QA), Quality Control (QC), Production/Manufacturing, and Corporate Regulatory teams.
- Nature of Interaction: Coordinating and collating technical documentation (BMR, BPR, stability studies, validation reports) ; reviewing change con

📌 Executive- RA EU (Govandi East)
🏢 USV
📍 Govandi East