Careers
Director/Senior Director of Regulatory Affairs
Apply NowArriVent Biopharma is looking for a talented and highly motivated regulatory affairs individual to execute global regulatory strategies aimed at the most efficient regulatory pathway for oncology drug and/or diagnostic development programs. This involves collaboration with cross-functional project teams in planning development strategies and leading global regulatory submissions for assigned projects, including for global marketing applications and initial new drug applications. This position reports to the Sr. Vice President of Regulatory Affairs, and is primarily remote, however, will require working closely with a cross-functional team based in the San Francisco Bay area. Some travel to the Burlingame, CA office will be required.
Key responsibilities:
- Serve as key regulatory team member with responsibility for regulatory strategies and submissions for assigned projects
- Provide regulatory guidance and strategy for support of product development and registration strategies, including broad regulatory oversight for nonclinical/clinical development
- Ensure high-quality and timely regulatory submissions (IND/CTA/NDA/MAA, as applicable) in compliance with all applicable regulatory requirements, and in alignment with corporate goals
- Act as the primary liaison with regulatory authorities
- Direct and assist internal staff and regulatory consultants, as required, to ensure compliance of drug development activities with all U.S. and international requirements
- Support due diligence and partnering activities, as needed
- Analyze and communicate current regulatory guidance and regulations, as well as industry and regulatory agency best practices and trends, to keep company informed on any relevant changes in the regulatory landscape
- Perform all duties in keeping with the Company’s core values, policies and all applicable regulations
Desired Skills:
- Recent NDA/BLA experience
- Proven ability to think strategically
- Proficient in written, oral, and interpersonal communications
- Ability to manage complexity and uncertainty
- Ability to work in a small company within a largely virtual environment; small biotech/pharma experience
- Embraces company core values
Education & Experience:
- BA/BS degree required in a biological/physical sciences or pharmacy. Advanced degree in related discipline preferred.
- 8 – 10+ years of regulatory affairs experience in the biotech / pharmaceutical industry
- Knowledgeable of US FDA and international pharmaceutical guidances, regulations, drug development process, and industry standard practices
- Experience in oncology