Company summary: An exciting biotech down in San Diego is looking to add a key member to their Regulatory team. This Senior Director will oversee all CMC activities, and work across several therapeutic areas, including oncology.
This mid-sized biotech boasts a great company culture, and has a lot of personal and professional benefits. If you're looking to join an exciting global firm with a lot of potential for growth - don't hesitate to apply!
RESPONSIBILITIES:
In this role you will be responsible for:
- Managing relevant submissions/projects
- Lead CMC activities
- GMP requirements, SOP's
- Assist management and oversight of global regulatory activities
- Other regulatory duties as relevant
REQUIREMENTS:
The client requires that all candidates have:
- BS or higher in relevant field
- 10+ years of industry experience
- Experience in small molecules
- Experience with CMC
- Experience with FDA/EU/Japanese regulations
