Regulatory Affairs Director
Remote
Company Summary:
My client is a global leader in the oncology space targeting the right immunotherapies to treat solid tumors. They are looking to add a fully remote Regulatory Affairs Director to their team. If onsite work is preferred, you can come on a hybrid basis into their office in Houston, TX!
The Regulatory Affairs Director will be responsible for:
- Leading Regulatory Affairs operations in the US and overseeing/participating in regulatory submissions and operations in the US
- Developing Regulatory strategies and implementation plans and feeding into cross functional teams
- Ensuring compliance with regulatory requirements and adhering to internal policies
- Supporting development for regulatory strategies including non-clinical development, manufacturing, clinical trial strategies and marketing authorization applications
The Regulatory Affairs Director should have the following qualifications:
- Bachelor's degree and 10+ years of Regulatory Affairs experience
- Strong leadership and team building skills (for a remote team)
- Experience with biologicals and/or cell & gene therapy in oncology is a plus
