Job Duties & Responsibilities:

• Collaborate with Business Development and Regulatory Affairs teams to develop dossier filing plans and ensure timely submission across target markets. Monitor approval and product launch timelines and escalate critical issues or delays as required.
• Prepare and manage the dossier filing budget on a monthly basis, ensuring optimal utilization of resources and adherence to project objectives.
• Act as the primary liaison among cross-functional teams, including R&D;, Production, Quality Control (QC), Quality Assurance (QA), Regulatory Affairs, Purchase, Packaging Development, and Corporate Quality Assurance (CQA), to facilitate effective execution of regulatory submissions and approvals.
• Track, monitor, and follow up on regulatory queries, deficiency letters, and customer/MoH (Ministry of Health) observations until successful closure, ensuring timely and effective responses.
• Proactively identify, assess, and mitigate project risks by monitoring progress against milestones, deliverables, and timelines.



Provide regular feedback and recommendations to stakeholders to ensure successful project execution.
• Generate and maintain Regulatory MIS reports, dashboards, and project status updates, providing timely visibility to internal stakeholders and management.
• Drive resolution of project-related challenges by facilitating effective communication and collaboration across cross-functional teams, ensuring prompt decision-making and issue resolution.
• Identify and implement prospects for process improvement, operational excellence, and project execution efficiency across the regulatory portfolio.
• Organize project review meetings; prepare and circulate meeting agendas, minutes of meetings (MoMs), action trackers, and follow-up reports to ensure timely closure of action items.
• Monitor day-to-day project activities and coordinate with stakeholders to ensure execution of deliverables in line with approved timelines and regulatory comm

📌 Assistant Manager Project Management Mumbai
🏢 Inventia Healthcare
📍 Mumbai