Description:

Project Planning and Execution: Define and manage the scope of post-approval projects. Develop and track project timelines to ensure timely completion. Set and achieve key milestones throughout the project lifecycle. Stakeholder Communication: Coordinate with R&D, manufacturing, marketing, and other departments. Communicate with regulatory bodies, healthcare professionals, and other stakeholders. Provide updates to internal teams and external partners. Documentation and Record Keeping: Maintain accurate records of compliance activities and changes. Keep thorough records of project plans, progress, and outcomes.

Essential Functions:

Introduction and tracking of new post-approval projects when received from SSSM or other cross-functional departments. Tracking of Existing material Inventory and highlight the importance of post-approval project completion. Coordinating with supply chain and procurement department for procurement of API samples, impurities and submission batch qty. Tracking of Vendor qualification and Method Validation and Verification activities on daily basis Coordinating with CFT’s on documentation, specification, method preparation and revision requirements. Tracking and scheduling the timeline for release of the material and drug product. Coordinating with operations for the submission batch schedule and stability initiation. Tracking of post-approval project throughout the completion of stability, filing and approval. Coordinating with RA and other CFTs for required filing documents and submission timeline. Providing confirmation of grant/approval status and implementation of post-approval project at commercial scale. Providing numerical data on cost-saving/alternate source projects. Project Selection: Actively participates in the supply chain management and forecast meetings. Mentors Senior Manager of Strategic Portfolio Management on the process and target products consistent with the company’s strategic objectives and based on knowledge of Brand and Generic pharmaceutical markets. Business Development: Works closely with Business Development and Corporate Development to identify and evaluate opportunities for alternate source and cost saving projects. Builds financial models to determine value and potential deal structures. Conducts due diligence on BD opportunities. Planning: Works closely with supply chain management, Operations, and Project Management on project timing and projections to ensure a smooth and effective completion of projects from either internal and external facilities. Assesses and provides critical input on timing, market dynamics, etc. that drive near- and long-term forecasts for Finance and Tech Ops. Market Intelligence: Analyzes products, markets, regulatory issues, companies, therapeutic categories, etc. to drive decisions on portfolio and new opportunities.