Job Summary
A staffing agency has an open position for a Remote CMC Regulatory Affairs Regional Senior Manager.
Core Responsibilities Include:
- Developing and applying a comprehensive understanding of global RA CMC regulations and guidelines for biological products
- Communicating and negotiating with Health Authorities as necessary, directly and indirectly
- Planning, executing and managing regulatory submissions for assigned products in various phases of clinical development
Applicants must meet the following qualifications:
- Bachelor's Degree in a Scientific or Technical Discipline, with 8+ years of experience in the pharmaceutical industry
- Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support
- Proven ability to provide strategic regulatory guidance to drug development, registration, and post-market support teams
- Knowledge of CTD dossier
- Able to deal with issues of critical importance with minimal supervision
- Demonstrates emerging leadership, problem-solving ability, flexibility and values teamwork
