Description
Job summary:Director of Regulatory Affairs - REMS
In this highly competitive director role, you will have a pivotal role in an exponentially expanding medical device and pharmaceutical company with cutting-edge technology. The primary responsibility of this position is the leadership and organization of Risk Evaluation and Mitigation Strategy for company products. Responsibilities include operation activities of the Safe Use Advisory Board, compliance with REMS requirements, and management of additional safe use initiatives.
Duties:
- Consistency, strategy, and implementation of REMS
- REMS execution including: interaction with internal and external partners, personal and team goals, FDA submission
- Interaction with Safe Use Board Chairperson
- REMS Program Companies monthly meetings
- Development of metrics and reporting mechanisms for management
- Maintenance and author of REMS procedural documents
Qualifications:
- REMS REMS / Risk MAPS / Risk Management Plans experience
- 5+ years management experience in with drug product experience in Regulatory Affairs
- Experience working in clinical side of regulatory
- Understanding of risk management drug safety
- BS, MS in related science field
If you are ready to take the next step in your career, please send your resume and I will respond with a follow-up phone call.
To find out more about Real please visit www.realstaffing.com