PURPOSE OF THE ROLE

To lead and coordinate cross-functional activities for injectable product development and commercialization. The role ensures timely project execution, budget control, CMO coordination, regulatory alignment, and stakeholder communication across functions.

KEY RESPONSIBILITIES AND ACCOUNTABILITIES OF THE ROLE

Conduct Stage Gate reviews and internal team huddles based on project phase.

Coordinate with cross-functional teams (FRD, ARD, API, RA, Packaging, Purchase, etc.) for seamless execution.

Track and follow up on project activities to ensure completion within agreed timelines.Monitor regulatory filing timelines and escalate delays, if any.

Prepare and circulate meeting minutes and action trackers.

Maintain and submit monthly MIS reports with high-level project updates by the 15h business day.

Organize and lead monthly/bi-monthly MIS meetings for injectable portfolio.

Act as point of contact for CMOs; manage weekly/bi-weekly progress calls.

Coordinate with external labs, track deliverables, and ensure timelines are met.

Prepare and track project cost sheets within 7 days of initiation.

Monitor budget utilization and escalate any deviations or overruns.

Develop business cases for alternate API vendors when needed.

Prepare and issue RFQs for CMO selection; visit CMOs and provide executive summaries

Track and support timely regulatory dossier submissions and MoH interactions.

Collaborate in understanding and contributing to QP/PE and CMO agreements.

Education Qualification : B.Pharma

Understanding of injectable formulation development lifecycle.CMO and Client interface and communication hold.





Regulatory filing requirements and CMC documentation knowledge.Budgeting, cost tracking, and resource planning.Hands-on experience with project tracking tools (e.g., MS Project, Excel, Smartsheet).

Experience required (What someone NEEDS TO HAVE DONE)

6-8 years of experience in pharmaceutical project management, preferably in injectables.Exposure to cross-functional coordination across R&D;, RA, Purchase,Manufacturing and BD.Proven experience working with Contract Manufacturing Organizations (CMOs)

Experience in understanding of regulatory submission across Global market Analytical R&D; (ARD)

Review analytical method development, validation timelines, and stability data.

Essential Leadership Competencies for the role(Need to be demonstrated or how they NEED TO BEHAVE)

1. Purpose led Transformation

2. Drive Results

3. Active Collaboration

4. Customer Empathy

Personal Attributes required(Personal qualities, motivations, and preferences likely to enhance performance in the role)

High attention to detail and documentation discipline.

Ability to work under tight timelines and manage pressure.

Agility in learning and adapting to agile project needs.Collaborative team player with strong interpersonal skills.Strong sense of accountability and initiative.

Domain/ Functional skills required

Project lifecycle management Regulatory and CMC understandingMIS reporting and data consolidationCost and budget trackingCMO management and outsourcingDocumentation and RFP preparation

Cross-functional coordination. Client handling and timely update sharing

📌 Manager Project Management (Thane)
🏢 Aarvi Encon
📍 Thane