Job Summary
The position will be responsible for the planning, monitoring, execution and risk management for launch of generic pharmaceutical products in emerging markets. This role involves coordinating with cross‑functional teams to ensure product launches from an in‑house manufacturing site comply with regulatory and quality requirements. The goal is to deliver launches within agreed timelines and budgets to achieve launch objectives. Scope of work includes first‑timeline launches, market extensions, second‑wave launches, and relaunches of in‑house manufactured products across dosage forms for emerging markets.
Key Responsibilities
- Project Management: Lead the end‑to‑end project for new product launch/introduction, including planning, execution and risk management using the IMPULSE process. Identify bottlenecks such as resource constraints and technical issues, and provide inputs for escalation to the senior team for de‑bottlenecking. Conduct structured weekly cross‑functional meetings with stakeholders (each plant) to understand constraints, project issues 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 a strong interface between markets and manufacturing—communicating market change dynamics to plant and NPLR impact. Work closely with MSTG‑Production to schedule scale‑up & characterization batches and launch batch execution. Engage with PDD and marketing for commercial pack style finalization, coordinating with procurement for material supplies and logistics team for launch projects.
- Market Analysis: Coordinate with marketing and BD to obtain updated BC, NPLR and evaluate project feasibility based on COGS and marketing business case. Conduct monthly project update meetings with marketing to provide visibility on product readiness and capture marketing inputs to improve service level.
- Regulatory Compliance: Update the launch calendar based on regulatory approval timelines and IP updates. Ensure all product 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 the 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 dashboards, launch calendar, launch project trackers, ES&OP, and monthly presentation.
Educational Qualification
- Bachelor’s degree in Pharmacy, Life Sciences, Business, or a related field. A Master’s degree or MBA is preferred.
Experience
- Tenure: 8‑12 years of experience in New Product Launch/Introduction, supply chain planning and project management within the pharmaceutical industry, specifically in generics. Prior experience in New Product Launch OSD and injectables dosage form is desirable.
The preceding job description has been designed to indicate the general nature and level of work performed by an employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).