Job Summary
A provider of outsourced development services has an open position for a Telecommute Biologics Regulatory Affairs Director.
Core Responsibilities Include:
- Actively anticipating, developing and implementing initial or alternative regulatory strategies
- Acting as scientific thought leader
- Providing clients with strategic advice in response to their queries
Must meet the following requirements for consideration:
- Bachelor's degree in a relevant discipline, preferably in life sciences, or other healthcare field
- 12-15 years related experience in Regulatory Affairs setting, in Pharma or CRO
- Experience supporting client development activities and people management
- Experience with small molecules, biologics, gene therapy and cell therapies
- Experience in regulatory writing, meeting packages, dossiers
