Title:  Manager - 1

Job Title: New Product Introduction Manager

Job Summary:

The position will be responsible for the planning, monitoring, execution and risk management for  launch of generic pharmaceutical products. This role involves coordinating with cross-functional teams ensuring product launches from in-house and CMO in   compliance with regulatory and quality requirements. Ensure launch within agreed timelines and budgets to achieve launch objectives. Scope of work include First Timeline Launches, market extension, 2nd wave launches, relaunches of in-house and in-license products across dosage forms for US, EU and emerging markets

Key Responsibilities:

• Project Management: Lead the end-to-end project for New Product Introductions including planning, execution and risk management using IMPULSE process.  Identify bottlenecks including resources constraints, technical issues & provide inputs for escalation to the senior team for de-bottlenecking. Conduct structured Weekly Cross Functional Meetings with stake holders (each plant) to understand constraints, project issue and drive launch activities

• Cross-Functional Collaboration: Collaborate with manufacturing, R&D, regulatory affairs, procurement, marketing, supply chain, and quality assurance teams to ensure successful product manufacturing, supply and launch. Act as strong interphase between Markets & Manufacturing - Communicate market change dynamics to plant & NPLR impact. Work closely with MSTG-Production to schedule scale up & characterization batches & launch batch execution. Engage with PDD and marketing for commercial Pack style finalization Co-ordination with procurement for material supplies and logistics team for launch projects

• Market Analysis: Co-ordination with marketing & BD to get updated BC and evaluate project feasibility basis COGS and marketing business case. Conduct Monthly Project Update Meetings with marketing team, providing visibility on product readiness & capturing marketing inputs for improving service level

• Regulatory Compliance: - Update launch calendar, based on regulatory approval timelines & IP updates. Ensure all products launches meet regulatory requirements for the market of interest, including local FDA guidelines and international regulations.

• Budget and Risk Management: Develop and manage project budgets, ensuring that projects are delivered on time and within budget constraints. Identify potential risks associated with product launch and develop mitigation strategies.
• Stakeholder Communication: Prepare project charter and present project updates to senior management and stakeholders. Facilitate communication between teams to ensure alignment on objectives and timelines.
• Continuous Improvement: Implement best practices and process improvements to enhance the efficiency of the NPI process.
• Reports – Update and maintain management dash boards, Launch Calendar,  Launch Project trackers,  ES&OP and Monthly Presentation

Qualifications:

• Education: Bachelor’s degree in Pharmacy, Life Sciences, Business, or a related field. A Master’s degree or MBA is preferred.
• Experience: 5+ years of experience in New Product Introduction, Supply Chain Planning and project management within the pharmaceutical industry, specifically in generics. Prior experience in New Product Launch of Topicals , Injectables dosage form is desirable
• Knowledge: Strong understanding of regulatory requirements for pharmaceuticals and experience with launch and product lifecycle management.
• Skills: Excellent in Supply Planning, Project Management, SAP and Microsoft Office skills. Proficient in using SAP, Microsoft office and Project Management Tools.
• Communication: Strong verbal and written communication skills. Ability to effectively present information to various stakeholders.
• Leadership: Proven ability to lead cross-functional teams and drive results in a fast-paced environment.