Transformation Project Coordinator

1 week ago

Gandhinagar, Gujarat, India beBeeProject Full time ₹ 22,00,000 - ₹ 30,00,000
**Job Title:** Technical Transfer Project ManagerKey Responsibilities:
  • Managing and coordinating Technology Transfer projects, tasks, schedules, status and project reporting to stakeholders independently.
  • Facilitating communication within and outside the project team.
  • Facilitating problem-solving & decision-making with respect to project deliverables and meeting timelines/tasks/"requests from project teams and other cross-functional departments.
  • Focusing on proactive planning to manage risk, remove barriers and meet goals.
  • Establishing project plan baselines and documenting assumptions.
  • Understanding business cases including competitive landscape, regulatory/clinical requirements, IP landscape and other potential external factors which may derail the project.
  • Preparing draft agendas, meeting minutes, presentations for project related meetings to varied stakeholders, including governance boards.
  • Reviewing relevant project specific documents.
  • Managing Reference Drug procurement and shipment - Compiling and monitoring completion of key development tasks through milestone completion, quality gates, and stage gating processes.
Requirements:

The successful candidate will have thorough knowledge of generic drug development cycle including complex generics, peptides, various regulatory guidelines, (ICH, ANVISA, USFDA, EMA) and regulations (GMP, GCP, GLP etc.). They should also have thorough understanding of eCTD dossier modules and various regulatory filing pathways for EU, US, CA, PMDA, LATAM etc.

They will be skilled in Microsoft Excel and PowerPoint presentations, as well as having expert-level experience in Formulation Development of solid oral dosage forms, Parenteral dosage form, Liquid dosage form, Topical dosage form, Nasal spray (Protein and Peptide Delivery System/Complex Parenteral Dosage forms will be added advantage).

Essential Qualifications:

Dynamic, self-driven, capable of working in a highly entrepreneurial environment, result-oriented, practical-minded, ready to travel different locations as per organizational need.

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