Manager - Project Management

Role & responsibilities

Accountable for initiating, planning, executing, monitoring & controlling and closing pharmaceutical development projects across regulated, semi-regulated, and domestic markets. To ensures timely execution of all project phasesfrom feasibility evaluation to regulatory submission—by collaborating with CFTs, managing resources, and tracking progress using MS Project and other tools like Excel, Power BI presentations within defined scope, schedule, cost, quality & compliance standard. Acts as the primary point of integration for all stakeholders throughout defined project lifecycle.

1. Feasibility Evaluation Phase

• Prepare and finalize project charter upon receiving request from CFT & share the charter with finance team for business case preparation for regulated market projects.
• And, for domestic projects collecting product details from BD to coordinate feasibility evaluation with stakeholders.

2. Project Initiation Phase

Create a new project in MS Project within five working days of receiving the PIF/NPI or request from BD/Finance, select the appropriate project type template (e.g., ANDA/Dossier, Dossier Extension, Site Transfer), complete all mandatory fields, transcribe details from the portfolio management system if available, trigger automated notifications to stakeholders, and update project status to HOLD or Dropped when required.

3. Scheduling & Planning

Accountable for defining project execution activities by customizing the Work Breakdown Structure (WBS), assigning resources, publishing the project schedule in MS Project within 15 days of project code creation, building and managing the project team throughout the lifecycle, setting baselines, monitoring progress against schedule, and reviewing and approving task updates from stakeholders.

4. Pre-requisite Management

Coordinate with CFTs to arrange licenses (NOC, Test, API/RLD import), raw materials (API, RM, PM, RLD), standards, and equipment for R&D initiation.

5. R&D Kick-off

Organize formal kick-off meeting with R&D stakeholders after pre-requisites are ready.

6. Development Phase

Ensure readiness and timely upload of RMBOM and PMBOM and track critical R&D activities such as analytical method development, stability data generation, method validation and transfer, NPI approval, and sampling plan availability.

7. Manufacturing Phase

Responsible for organizing site kick-off meeting post NPICC initiation for tech transfer and batch execution, co-ordinate with AMD/QC for analytical method validation and specification issuance, working with purchase team for RM, PM, change parts, and equipment procurement, and overseeing execution of Scale-up, Process Optimization, and Exhibit batches until stability initiation.

8. BE Study Coordination

Co-ordinate CRO-related activities: BE-NOC, RLD procurement, test batch samples, COAs, and other BE study requirements.

9. Regulatory Submission Phase

Accountable for ensuring the availability of all documents required for regulatory submissions, coordinating with CFTs for dossier filing, responding to regulatory queries within deadlines, and managing variation filings as per RA checklist.

10. Communication Management

Trigger automated notifications upon project creation and updates, provide regular status reports to BD, RA, and senior management, and conduct kick-off meetings for R&D and manufacturing phases to ensure stakeholder alignment.

11. Risk Management

Responsible for identifying risks related to timelines, resource availability, and regulatory compliance, escalating issues promptly, and implementing mitigation strategies to minimize project delays.