Who We Are…
BeyondSpring Inc. headquartered in New York is a global biotechnology company developing novel therapeutics for cancer patients. The lead asset, Plinabulin is in phase III clinical trials for the prevention of both non-small cell lung cancer (NSCLC) and chemotherapy-induced neutropenia (CIN). BeyondSpring Inc. is built on innovative minds working together with a passion to advance it's platform to treat cancer and reduce the impact of treatments on patients.
We Are Looking For…
A Director of Regulatory Affairs will provide leadership on global clinical regulatory activities. Responsibility will mainly focus on clinical regulatory filings and provide strategic as well as operational leadership on the project teams in this area. In addition, responsibilities will include support to on-going clinical activities. The candidate will contribute and/or lead IND/CTA and NDA/MAA submissions activities for BeyondSpring clinical asset candidates.
- This position involves the ability to integrate/apply knowledge of global regulations governing pharmaceutical drug development of all aspects of BeyondSpring’s quality (CMC) , preclinical and clinical drug development programs, policies, and procedures, so that Development teams can meet all objectives within specified timelines and so that the necessary state of compliance is maintained relative to all regulatory commitments/requirements.
- Develop regulatory strategies for assigned programs in collaboration with BeyondSpring’s Chief Regulatory Officer and by analysis of regulatory guidance documents and assessment of drugs developed with similar indications to BeyondSprings’ drug products to obtain approval of activities in support of development and marketing objectives within specified timelines.
- Management of the planning, preparation, and submission of licensing applications (NDA/MAA).
- Continually monitor newly published FDA guidelines and international guidance documents in the context of new and ongoing development programs.
- Provide training on applicable requirements for scientific staff as required.
- Manage and mentor direct reports and/or junior staff members.
Required Qualifications for Consideration Are…
- MS or Ph.D. preferred.
- A minimum of 10 years of pharmaceutical industry experience.
- 6 years of regulatory experience and management experience.
- We seek candidates who possess excellent written, verbal communication.
- Technical skills (e.g. Microsoft Office suite, Regulatory Information Management Systems (REMS), Document Management Systems.
- Command of Mandarin Language is a significant attribute but not mandatory.