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 Current 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

Professional 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 Knowledge: Deep understanding of ICH Guidelines, GMP (Good Manufacturing Practices), and regional requirements for US, EU, and Emerging Markets.

Software Proficiency: Hands-on experience with eCTD publishing tools and document management systems.

Soft Skills: High attention to detail, strong negotiation skills for dealing with agencies, and the ability to translate complex technical data into clear regulatory narratives.

Academic Qualifications & Certifications

Educational Qualification:

Master’s degree in Chemistry or related Life Sciences.

Professional certification in Regulatory Affairs (e.g., RAC) is a significant advantage.

📌 Senior Executive - Regulatory Affairs (API) (India)
🏢 USV
📍 India