Careers

Associate Director of Regulatory Affairs, CMC

Position Summary

ArriVent Biopharma is looking for a talented and highly motivated CMC regulatory affairs professional to support development and execute global CMC regulatory strategies aimed at the most efficient regulatory pathway for oncology drug programs, including preparation and oversight of CMC and Quality-related agency correspondence and regulatory applications. This position will be responsible for and support regulatory activities to provide high-quality CMC sections of regulatory documentation. This position is primarily remote; however, some travel to Burlingame, CA and/or to Gaithersburg, MD will be required.

Key Responsibilities

• Serve as key CMC/regulatory team member with responsibility for CMC regulatory strategies and submissions for assigned projects
  • Provide regulatory guidance and phase-appropriate strategy for CMC aspects of product development strategies to manufacturing, quality, clinical supply team and development team.
  • Review and prepare CMC-related regulatory documents (e.g. IND, IMPD, NDA/BLA, MAA, as applicable) and ensure these documents are in compliance with all applicable regulatory requirements, and in alignment with corporate goals
  • Lead CMC meetings with regulatory agencies with support from technical subject matter experts
• Collaborate and liaise with internal staff and CMC regulatory consultants, as required, to ensure compliance of drug development activities with all U.S. and international requirements
• Develop regulatory processes and procedures to support CMC components of regulatory submissions
• Analyze and communicate current CMC regulatory guidance documents, regulations, and directives, as well as industry and regulatory agencies (US, EU, and Japan) best practices and trends, to keep company informed on any relevant changes in the regulatory landscape and advise Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programs
• Perform all duties in keeping with the Company’s core values, policies and all applicable regulations

Desired Skills

• 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 preferred

Education & Experience

• BA/BS degree in a scientific/engineering discipline. Advanced degree preferred.
• Experience in biologics or antibody-drug conjugates required.
• 5+ years related experience in the biotech or pharmaceutical industry
• Knowledgeable of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices