Director, Regulatory CMC

Full Time
Posted 2 months ago

Position Summary:
ArriVent Biopharma is looking for a talented and highly motivated CMC regulatory affairs leader to develop 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 lead and support all regulatory activities to provide high quality CMC sections of regulatory documentation. This position can be located either in the San Francisco Bay area or in the Greater Washington DC area.

Key responsibilities:

  • Serve as key CMC/regulatory team member with responsibility for CMC regulatory strategies and submissions for assigned projects and identification of risks
    • Provide regulatory guidance and strategy for CMC aspects of product development and registration strategies to manufacturing and quality team and development team; evaluates CMC change controls
    • Ensure high-quality and timely CMC regulatory submissions (IND/CTA/NDA/MAA, as applicable) 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
  • Direct and assist 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‚Äôs 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.
  • 7+ years regulatory affairs experience in the biotech or pharmaceutical industry
  • Knowledgeable of US FDA and international pharmaceutical guidances, regulations, drug development process, and industry standard practices
  • Experience with NDA submission (Module 3) and approval in US and EU
  • Experience in leading CMC meetings with regulatory agencies
  • Experience in oncology required

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