Senior Regulatory Affairs and Quality Assurance Leader

4 weeks ago

Reston, Virginia, United States Terns Pharmaceuticals Full time
About the Role

Terns Pharmaceuticals is seeking a highly experienced and skilled Vice President, Regulatory Affairs and Quality Assurance to lead our regulatory and quality functions. As a key member of our Senior Leadership Team, you will be responsible for developing and executing regulatory strategies, managing global health authority interactions, and overseeing quality operations to ensure compliance and successful progression through clinical development and approval processes.

Key Responsibilities
  • Develop and execute regulatory strategies for small-molecule product candidates in oncology and obesity.
  • Manage interactions with FDA, EMA, and other global health authorities to ensure regulatory milestones are met.
  • Oversee regulatory submissions, including INDs, NDAs, and MAAs, ensuring compliance with global standards.
  • Provide strategic leadership of the quality team and collaborate with the existing QMS personnel to maintain compliance with regulatory standards (FDA, ICH, EMA).
  • Work cross-functionally with clinical, manufacturing, and non-clinical teams to ensure alignment between regulatory and quality efforts and corporate goals.
  • Manage and lead the regulatory and quality teams, ensuring cohesive execution of regulatory and quality strategies.
  • Stay current with evolving regulatory requirements and provide guidance on regulatory and quality compliance, particularly in oncology and obesity.
  • Contribute to the development of corporate strategy, ensuring regulatory and quality perspectives are integrated into decision-making processes.
Requirements
  • 10+ years of regulatory experience in the pharmaceutical or biotechnology industry, with a focus on small molecules.
  • Proven success managing regulatory interactions with FDA, EMA, and other global health authorities.
  • Experience overseeing quality systems in a regulatory capacity, with strong understanding of compliance standards (FDA, ICH, EMA).
  • Demonstrated success in regulatory submissions, including IND, NDA, and MAA filings.
  • Experience in oncology and/or obesity therapeutic areas is highly desirable.
  • Bachelor's degree in a science-related field is required; an advanced degree is preferred.
Competencies
  • Setting Strategy
    • The ability to create and articulate a clear regulatory and quality strategy that aligns with the company's broader objectives, particularly in the development of small-molecule product candidates in oncology and obesity.
    • A data-driven approach to decision-making, seeking regulatory insights from multiple sources, and aligning the regulatory and quality strategy with corporate goals.
    • An entrepreneurial mindset that encourages innovation within the regulatory framework, exploring novel regulatory pathways such as accelerated approvals and combination development strategies.
    • The ability to balance ambitious strategic objectives with regulatory realities, creating realistic and actionable implementation plans that ensure compliance while driving innovation.
    • Executing for Results
      • Demonstrates the ability to set clear, challenging regulatory and quality goals, driving the organization toward compliance and successful submission of key documents (INDs, NDAs, MAAs).
      • Ability to manage ambiguity, adapt nimbly to regulatory changes, and lead the organization through complex regulatory environments and shifting quality standards.
      • Takes well-informed risks by collaborating with cross-functional teams to anticipate regulatory hurdles and quality challenges, ensuring a proactive approach to compliance and regulatory submissions.
      • A leader of high integrity who approaches decisions with transparency, consistently weighing the long-term impact on both the regulatory and quality functions and the overall organization.
      • Leading Teams
        • Skilled in attracting, recruiting, and developing top regulatory and quality talent, delegating responsibilities effectively while fostering a culture of continuous improvement.
        • Demonstrates resilience in overcoming regulatory and quality challenges, commanding respect by maintaining high standards and ensuring operational excellence across all regulatory submissions and quality processes.
        • Self-reflective and aware of personal limitations, driving organizational performance by leading with humility, being open to feedback, and continuously seeking self-improvement.
        • Relationships and Influence
          • Builds strong relationships across regulatory agencies, internal teams, and external partners, demonstrating high emotional intelligence and persuasive communication skills.
          • Inspires trust within the regulatory and quality teams, as well as with cross-functional teams, by leading with passion and conviction in their regulatory strategy and quality oversight.
          • Shares the spotlight with team members, celebrating both individual and team successes, and fostering a collaborative culture across departments.
          • Creates a strong sense of purpose for the regulatory and quality teams, aligning them with the company's mission to address serious unmet medical needs through the development of innovative therapies.

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