Company summary: A pre-IPO biotech here in the Bay Area is looking to add a new member to their growing Regulatory team. They're working on a diverse pipeline with products in a variety of therapeutic areas, including immuno-oncology and the autoimmune space. This company has an approved product already on the market, and are planning to file four additional NDAs by 2022.
In addition to the impressive scientific aspect, the office is close-knit and plans for long-term progression, thus making for a great culture and room for personal and professional growth.
RESPONSIBILITIES:
In this role you will be responsible for:
- Overseeing relevant documentation
- Directing regulatory submissions
- Working directly with relevant health authorities and company project leads
- Other relevant regulatory duties
REQUIREMENTS:
The client requires that all candidates have:
- BS or higher in relevant field
- 5 years of industry experience
- A track record of successful drug submissions/approvals
- Experience with the FDA/EU/Chinese regulations
- Strong communication skills
- Proficiency in Chinese
