Summary of Position:

ArriVent Biopharma is looking for a talented and highly motivated regulatory affairs leader to develop and 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. This position reports to the Vice President of Regulatory Affairs.

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:

  • 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 required in a biological/physical sciences. 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 in oncology required

Summary of Position:

Responsible for the execution of the ArriVent Quality Systems, Operations and associated support processes and will interface directly with 3rd party vendors, Technical Operations, Regulatory, Clinical Development and Clinical Operations teams to support and achieve Quality and Compliance goals. Some interface and influence of leadership is required with input on key global QA / Compliance and business initiatives. Responsible for the monitoring of external regulatory compliance environment and making recommendations to Management on tactical issues impacting ArriVent business.

Position includes the following: GxP Auditing of internal and external services utilizing risk-based strategy; Managing Document systems; Change management utilizing a risk-based approach and root cause analysis. Implementing and utilizing Quality Management tools (Paper/Electronic system). Product release utilizing systematic process flows. Review documents such as SOPs, deviations, change control requests, corrective and preventive action plans, validation protocols/reports, technical reports, etc., that are submitted to QA for approval. Interprets and implements quality procedures, manages quality systems, and assists in facilitating regulatory compliance inspections. Approve SOPs, batch record and deviations. Strong time management skills. Host and manages Regulatory and 3rd party audits.  May travel internationally and interact with regulatory organizations.

Key Responsibilities:

  • Manage and implement GxP Quality systems including oversight and management of trial master file, SOPs, training, and audit program
  • Provide strategic direction for electronic quality system setup and configuration
  • Collaborate and establish, maintain procedures with technical teams to ensure that clinical supply and manufacturing activities are conducted in compliance with applicable GxP requirements.
  • Host and manages Regulatory and 3rd Party Audits
  • Oversee GMP operations at CMOs including quality review of batch records, analytical data, and lot disposition activities of, bulk substance, drug product, packaged and labeled drug products.
  • Lead investigations for any non-conformances during GxP activities
  • Manage the review and release of all products for which the ArriVent holds the IND or equivalent investigational application.
  • Lead and conduct GxP audits on suppliers, issue audit agendas, reports, findings, perform follow-up actions and escalate findings to management, as necessary.
  • Oversee GCP compliance with respect to clinical site and CRO audits
  • Oversight, management, and qualification of all GxP vendors
  • In conjunction with Clinical Operations management, assures appropriate oversight of clinical trial execution
  • Ensure compliance with applicable internal and external regulations, standards, policies and procedures related to the quality and regulatory status and performance of company operations, processes and products, including GMP, GLP, and GCP
  • Maintain compliant quality system that adheres to FDA regulatory expectations both internally and with respect to oversight of the company’s vendors
  • Work with CMC, Clinical, Regulatory, etc as an active cross-functional team member to ensure the appropriate document/data integrity for regulatory submission and regulatory inspections to ensure that the organization is inspection ready

Desired Skills and Experiences:

  • 7 years of experience with increasing levels of responsibility within the Quality and/or Compliance area. This includes hands on experience with managing inspections within the Clinical and R&D areas
  • Knowledge of US and Worldwide GxP regulations and experience with regulatory compliance inspections.
  • Compliance / QA experience at a pharmaceutical / biopharmaceutical
  • Extensive experience with GxP systems approaches and implementation of such systems
  • Proven ability to work in a collaborative team environment across multiple technical functions.
  • Ability to effectively interact with both global functional areas (GxP) and manufacturing sites (GMP) and third party vendors.
  • Strong project management and organizational skills.
  • Excellent interpersonal skills (including, listening, writing, negotiation, facilitation, attention to detail and presentation skills).

Education:

  • B.S. in Biology, Chemistry, Engineering or related fields preferred.

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’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.
  • 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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