
Technical Transfer Project Manager
1 week ago
This role oversees the management and coordination of Technology Transfer projects, tasks, schedules, status, and project reporting to stakeholders.
- Responsibilities include managing project deliverables, facilitating communication within and outside the team, problem-solving & decision-making with respect to project objectives and meeting timelines/tasks/requests from cross-functional departments.
- Focusing on proactive planning to manage risk, remove barriers, and meet goals. Establishing project plan baselines and documenting assumptions is also key.
- Full understanding of business cases, including competitive landscape, regulatory/clinical requirements, IP landscape, and external factors that may impact the project.
- Preparing draft agendas, meeting minutes, presentations for project-related meetings to various stakeholders, including governance boards.
The ideal candidate should have:
- A Master's degree in Pharmacy or a related field, along with an MBA qualification.
- At least 9 years of experience in Project Management, particularly 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 an added advantage).
- Thorough knowledge of generic drug development cycle, including 505(B2), complex generics, peptides, various regulatory guidelines, (ICH, ANVISA, USFDA, EMA) and regulations (GMP, GCP, GLP etc.).
- Understanding of eCTD dossier modules and various regulatory filing pathways for EU, US, CA, PMDA, LATAM etc.
Core Competencies
- Dynamism
- Self-motivation
- Ability to work in a fast-paced environment
- Result-oriented approach
- Practical mindset
Why this Role?
This position offers exciting challenges to learn and grow every day. It provides a supportive environment where ideas are valued, and your voice is heard. With ongoing training and development opportunities, you'll have the chance to reach your full potential. We recognize excellence by offering competitive compensation packages and employee rewards programs that acknowledge contributions and achievements. Our culture is fun and inclusive, celebrating successes and building strong connections within our team.
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