Director/Senior Director Regulatory Affairs
A Clinical Stage biotechnology company that is focusing in tumor targeted therapies is currently seeking a Director/Senior Director regulatory affairs to join the team for a remote contract.
Responsibilities:
- Assist in development and implementation of global regulatory strategies including early and late development, registration and post approval
- Communicate and implement regulatory strategy
- Lead and manage regulatory team
- Prepare risk assessment and risk management and mitigation plans
- Work within Clinical, nonclinical and CMC to develop strategy
- Review all documentation for argument and risk assessment
- Confirm an information submitted to regulatory health authorities
- Ensure regulatory compliance
Requirements:
- BS or MS in a scientific or health care discipline
- 15+ years pharmaceutical industry experience
- 8+ years regulatory affairs experience
- Management experience (preferred)
- Strong understanding of drug development and knowledge of FDA requirements
- Direct FDA and international experience required
- Strong attention to detail
- Strong verbal and written communication skills
- Knowledge of electronic publishing/file management system experience
If interested in the Director/Senior Director Regulatory Affairs position don't hesitate, apply now!
