Assistant Manager- Project Management

Inventia Healthcare Limited; Mumbai; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

Inventia Healthcare Limited is seeking a Project Manager for Regulatory Affairs in Mumbai. The role focuses on developing dossier filing plans, coordinating submissions across markets, and ensuring timely launches.

You will liaise with R&D, Production, QC/QA, Regulatory Affairs, and other functions to monitor timelines, address queries, and drive risk-managed project execution. The position requires strong communication and regulatory lifecycle knowledge.

Qualifications

• Minimum 3-6 years of relevant experience in Project Management and Regulatory Affairs in pharma.
• Experience coordinating regulatory submissions and approvals across markets.
• Strong stakeholder communication and cross-functional collaboration.

Responsibilities

• Collaborate with BD and Regulatory to develop dossier filing plans and timely submissions.
• Monitor approval timelines and escalate delays as required.
• Prepare and manage monthly dossier filing budget.
• Act as liaison among R&D, Production, QC/QA, Regulatory, Purchase, Packaging, CQA.
• Track regulatory queries and deficiency letters to successful closure.
• Identify and mitigate project risks; provide status updates and recommendations.
• Generate Regulatory MIS reports and dashboards for stakeholders.
• Drive cross-functional resolution of project challenges and decisions.
• Organize project reviews with agendas, MoMs, action trackers and follow-ups.
• Maintain project dashboards, submission trackers, launch plans and LRPs.
• Ensure alignment of priorities with regulatory requirements and business commitments.

Skills

Project planning

Stakeholder management

Regulatory submissions

Lifecycle management

Communication

Risk management

Multitasking

Cross-functional

Reporting tools

Analytical thinking

Tools

Microsoft Excel

PowerPoint

Job description

• 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 elevate 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 efficient 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 opportunities 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 commitments.
• Develop, standardize, and continuously improve project management tools, processes, trackers, and best practices to enhance project visibility and execution effectiveness.
• Maintain and regularly update Project Management dashboards, regulatory submission trackers, approval trackers, launch plans, and Long-Range Planning (LRP) documents.
• Ensure alignment of project priorities with organizational objectives while maintaining compliance with applicable regulatory requirements and business commitments.

Core Competencies:

• Strong project planning, tracking, and stakeholder management skills.
• Sound understanding of global regulatory submission processes and lifecycle management.
• Excellent communication, coordination, and problem-solving abilities.
• Ability to manage multiple projects simultaneously in a fast-paced environment.
• Proficiency in project tracking tools, Microsoft Excel, PowerPoint, and reporting systems.
• Strong analytical mindset with a focus on risk management and continuous improvement.

Job Specifications:

• Minimum 3-6 years of relevant experience in Project Management and Regulatory Affairs within the pharmaceutical industry.