Company: Umedica Laboratories
Post: Project Management manager R&D
Experience: 10-15 yrs
Qualification: Relevant
Location: Navi Mumbai
Job Description :
- Project Manager to take ownership of the entire project for formulation products and timely delivery of ANDA and MAA for submission with US FDA and EU Authority.
- Project Selection Decisions on the USA and Europe Market
- Define project scope, goals and deliverables that support business goals in collaboration with senior management and stakeholders. Planning Scope, Schedule, Cost, Quality, Human Resource, Procurements
- Activity Planning and Sequencing; Developing Project Schedule and Budget. To understand projects, define milestones, plan activities, track progress and coordinate
with external and internal stakeholders' commitments
- Timely review of the progress of the project to ensure deliverables on time and ensure the project is well within budget, time and legal framework
- Risk Management of Project. To explore avenues to accelerate the project, identification of potential risk and steps to mitigate the same.
- Project decision/ escalation to Management for either resource constrain or additional cost approval
- Exposure to formulation development, compliance to regulatory requirements in early stage of career is required in managing
- Handling of timely response to agencys deficiencies on ANDA or MAA.
- Must be able to use project management tools (MS Project)
- Proficient in communication and conducting productive meetings.
- Liaising with other functions; like Formulation and Development, Quality, Supply Chain Management, Packaging Development etc. to ensure the smooth progress of the project.
- Keep track of the project milestones and deliverables. Provide routine project status to the project team and top management. Monitoring and Presentation on Progress of Project
- Identify and resolve the issues and conflicts within the project team.
- Preparation of monthly project progress report for top management council. Responsible for project communications through PowerPoint presentations and minutes for meetings.
- Designing Strategy and Planning of US and EU Deficiencies. Review the agency's deficiencies and identify the detailed requirements in order to timely respond the deficiency. Brainstorming the various strategies with other stakeholders to respond to US FDA’s deficiencies on ANDAs/MAAs, amendments, or supplements thereof.
Candidates possessing excellent exposure in the above area with around 8-15 years of Experience in Project Management from reputed Pharma companies are invited to apply.
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