Opportunity For Project Management at Macleods Pharma (Mumbai)

Macleods Pharmaceuticals; Mumbai; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Macleods Pharmaceuticals in Mumbai is seeking an experienced project management professional to drive dossiers across injectables, ophthalmic, oral solid and liquid dosage forms. You will plan timelines, coordinate development activities, and ensure on-time submissions.

You will monitor progress with Excel, manage teams, and liaise with R&D, Regulatory, QA/QC, Marketing and Procurement to align strategies. The role also involves identifying new products and preparing business cases for market

Responsibilities

• Project planning and execution to ensure timely dossier submission for injectables, ophthalmic, oral solids and liquids.
• Prepare project timelines for formulation/analytical development, scale-up, validation and filing.
• Track project progress by monitoring timelines using Excel sheets.
• Team management and tracking of ongoing projects for timely completion.
• Monitor projects and coordinate with internal departments under approval stages.
• Finalize project strategies and scheduling.
• New product selection and business case preparation.
• Coordinate with R&D, Regulatory, QA/QC, Marketing, Procurement, etc.
• Support regulatory filings for regulated and emerging markets with timely document availability.
• Introduce new products (US, EU, PEPFAR, AU, CA & ROW) and 505(b)(2) US in R&D with portfolio team.

Job description

Role & responsibilities

• Project planning and execution with minimizing constraints in project life cycle for timely submission of dossier for Inject able, Ophthalmic, Oral solid and liquid dosage forms.
• Preparation of project timelines for formulation and analytical development, scale up, validation, stability until filing.
• To maintain and track project progress by monitoring timelines with excel sheets.
• Team Management, Managing and tracking the ongoing projects for timely completion.
• Project Monitoring, Execution, and coordination with the internal Department for all under approval stages.
• Finalization of Project strategies and scheduling.
• New Product Selection, Business Case Preparation
• Co-ordination with internal departments R&D, Regulatory, QA/QC, Marketing, Procurement, etc.
• To provide support in regulatory filings for Regulated and emerging markets by managing timely availability of documents required for dossier submission.
• Introduction of New Product & (US, EU, PEPFAR, AU, CA &ROW) and 505(b)(2) product (US) in R & D by discussion with portfolio team.