Manager - Project Management

Aarvi Encon; Mumbai; Sur place; INR 1 800 000 - 3 000 000; Plein temps

Résumé du poste

Aarvi Encon in Mumbai seeks a B. Pharm professional with 6-8 years of pharmaceutical project management experience, preferably in injectables, to drive cross-functional programs across R&D, RA, Purchase, Manufacturing and BD.

The role requires CMOs engagement and strong regulatory/submission awareness. You will conduct Stage Gate reviews, coordinate with FRD/ARD/API/RA/Packaging/Purchase teams, track timelines, and prepare MIS reports and cost trackers.

Qualifications

• B. Pharm in Pharmaceuticals with 6-8 years of project management experience.
• Experience with cross-functional coordination across R&D, RA, Purchase, Manufacturing and BD.
• Proven experience working with Contract Manufacturing Organizations (CMOs).
• Understanding of regulatory submissions across global markets; project lifecycle management; regulatory and CMC knowledge.

Responsabilités

• Conduct Stage Gate reviews and internal team huddles.
• Coordinate with cross-functional teams (FRD, ARD, API, RA, Packaging, Purchase, etc.).
• Track project activities to ensure timelines.
• Monitor regulatory filing timelines and escalate delays.
• Prepare and circulate meeting minutes and action trackers.
• Maintain and submit monthly MIS reports with high-level project updates by the 15th 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.
• Prepare 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.

Connaissances

Project management

Cross-functional coordination

CMO management

Regulatory submissions

MIS reporting

Budget tracking

RFP preparation

Vendor management

Client handling

Stage Gate reviews

Formation

B. Pharm in Pharmaceuticals

Description du poste

B. Pharm in Pharmaceuticals, 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 Project lifecycle management Regulatory and CMC understanding MIS reporting and data consolidation Cost and budget tracking CMO management and outsourcing Documentation and RFP preparation Cross-functional coordination Client handling and timely update sharing

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 elevate 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 elevate any deviations or overruns. 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.