Senior Manager – Regulatory Affairs (DMF)

About the role

We are seeking a Senior Manager to lead regulatory activities related to Drug Master Files (DMF) within our pharmaceutical development pipeline. The role will support new molecule projects, ensure compliance with health‑authority requirements, and act as a key liaison between cross‑functional teams and customers.

Key responsibilities

• Participate in new molecule development and provide regulatory input.
• Lead CMC discussions and troubleshoot with cross‑functional teams for DMF compilation.
• Review DMFs according to health‑authority and customer requirements.
• Prepare and submit DMFs in CTD and eCTD formats.
• Conduct DMF gap analysis and implement risk‑mitigation strategies.
• Support customer qualification, AP DMF, DS/DP registration, and QP audit reporting.
• Manage regulatory agency queries, develop action plans, and submit responses.
• Assess change controls (CCF) for DMF impact and handle post‑approval change notifications.
• Provide customer migration support, maintain business continuity, and track DMF submissions, amendments, and annual reports.
• Monitor regulatory commitments, ensure completeness, and obtain SAP clearance for supply.
• Assist cross‑functional teams with APQR, CAPA, OOT/OOS investigations, and customer audits.

Required profile

• Senior‑level experience in regulatory affairs within the pharmaceutical industry.
• Proven track record managing DMF compilation, submission, and lifecycle activities.
• Strong understanding of health‑authority expectations and customer requirements.
• Excellent communication skills for interfacing with cross‑functional teams and external agencies.

Required skills

• DMF compilation and management.
• CTD/eCTD submission expertise.
• Regulatory gap analysis and risk mitigation.
• Change control (CCF) impact assessment.
• Post‑approval change management and customer notification.
• SAP clearance processes for supply.
• Tracking of regulatory commitments and submission timelines.