Company summary: An exciting, growing biotech company with internationally approved products is looking to build their regulatory team in the Bay Area! They have several drugs in Phase III of clinical trials (with additional drugs in other phases, making for a very stacked pipeline!), and are planning on getting two NDA's on the market this year, and another two in 2021. They're working in various therapeutic areas, with an emphasis in ImmunoOncology and Biosimilars, making for a faster process in clinical trials!
They're looking for someone to join up as a Manager or Senior Manager of Regulatory Affairs. Company culture is fantastic, and employees here get some great professional and personal benefits. If you're interested in learning more about this company and their vision for 2020, please don't hesitate to apply!
RESPONSIBILITIES:
In this role you will be responsible for:
- Leading regulatory functions, both submissions and strategy
- Building strong relationships and collaborating with global Health Authorities
- Lead ad mentor teams
- The review of regulatory documentation
- Other general regulatory duties, falling in conjunction with title
REQUIREMENTS:
The client requires that all candidates have:
- Bachelor's degree or higher in relevant field
- 6+ years relevant experience
- Track record of successful drug submissions/approvals
- Understanding of global regulations
- Strong communication skills
*Applicants must have relevant regulatory experience, and a strong understanding or fluency in Chinese, please include a note stating level of proficiency on your resume*
