Job Description
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. Educational Qualification Academic Qualifications & Certifications Master’s degree in Chemistry or related Life Sciences. Professional certification in Regulatory Affairs (e.g., RAC) is a significant advantage.

📌 Executive- API RA (India)
🏢 USV Private
📍 India