
Senior Technology Transfer Project Manager
2 weeks ago
We are seeking an enthusiastic and self-driven project manager to join our dynamic team. This is a perfect opportunity for someone who thrives in a fast-paced environment and loves tackling new challenges.
- Manage technology transfer projects, tasks, schedules, status, and project reporting to stakeholders independently.
- Facilitate communication within and outside the project team.
- Facilitate problem-solving & decision-making with respect to project deliverables and meeting timelines/tasks/'requests from project teams and other cross-functional departments.
Key Responsibilities
The ideal candidate will have a thorough understanding of generic drug development cycles, including 505(B2), complex generics, peptides, various regulatory guidelines (ICH, ANVISA, USFDA, EMA) and regulations (GMP, GCP, GLP etc.). They should also have knowledge of eCTD dossier modules and various regulatory filing pathways for EU, US, CA, PMDA, LATAM etc.
Requirements
- Qualification: M. Pharmacy or B. Pharmacy with MBA.
- Experience: At least 9 years of experience in Project Management with prior experience in formulation development of solid oral dosage forms, parenteral dosage form, liquid dosage form, topical dosage form, nasal spray.
- Should have thorough knowledge of formulation development, including solid oral dosage forms, parenteral dosage forms, liquid dosage forms, topical dosage forms, nasal sprays.
Benefits
Our company offers exciting challenges, a supportive environment, career development opportunities, recognition of excellence, and a fun and inclusive culture.
Core Competencies
- Dynamic
- Self-Driven
- Capable to work in a highly entrepreneurial environment
- Result-oriented
- Practical mindset
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