Job Purpose:

Plan, monitor and execute R&D projects within budget and time to secure the launches as per the business need

Key Responsibilities:

Drive successful product approval by developing product development strategy and a detailed work plan to ensure successful project delivery within the laid down parameters of time and cost

- Create detailed Project development plan, Timeline, cost, milestones, critical path along with resource allocation in line with business requirement

- Communicate and align project team members in line with project plan on timelines, resources

- Manage license activities in coordination with regulatory team

- Manage and de-bottleneck logistic issues for availability of API, Innovator, Raw materials, test samples etc. as an when required to ensure smooth execution

- Ensure on time execution of feasibility/Assessment/regulatory /DMF batches, bio studies, filing by conducting periodic review meetings with units

Mitigate risks proactively by monitoring project progress against identified risks, tracking deliverables, reviewing milestones and providing feedback and information to the Project team to ensure timely execution

- Lead project stage gate meetings to review milestones, actual costs, provide weekly project status and escalate issues for deviation of scope

- Manage conflict and bring quick resolution to difficult problems through timely intervention and by facilitating and strengthening the interaction between CFTs

- Track and drive regulatory and quality compliance requirements, deviation and change controls

- Lead project risk mitigation workshop to identify risks involved to projects, prepare mitigation plan and ensure execution of the same

Drive effective project communication to ensure sound decision by doing cross functional project team meeting and sharing consistent information across stakeholders

- Ensure timely analysis and reporting to enable accurate information sharing

- Lead project meeting with CFT member for project key decision

Build relationship with Business team, portfolio and external customer by sharing project progress, doing project review meetings for achieving targeted deliverables

- Share monthly project status reports to BD and Portfolio

- Share SOW, team sheet with legal, Business, Quality and CMO team

Ensure continuous improvement of internal processes and project execution by monitoring progress for smooth functioning of the projects

- Ensure compliance to the operational excellence initiatives like 6 month planner for manufacturing batches in unit

- Managing adherence to stage gate process

- Provide detailed Project handover document to the corporate project managers post filing to ensure seamless integration

- Provide lessons learned during deficiency response, launch review meetings post filing to CFTs

Educational Qualifications: B. Pharm/M. Pharm/ MSc preferably PMP certified

Relevant Experience: Prior or current experience in the field of product development and/ or project management in Pharmaceutical industry

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