Vice President, Regulatory Affairs and Quality Assurance

Who We Are 

Who We Are Looking For 

What You’ll Do 

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  Lead global regulatory strategy development for small-molecule product candidates in oncology and obesity. 

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  Manage interactions with FDA, EMA, and other global health authorities to ensure regulatory milestones are met. 

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  Oversee regulatory submissions, including INDs, NDAs, and MAAs, ensuring compliance with global standards. 

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  Provide strategic leadership of the quality team and collaborate with the existing QMS personnel to maintain compliance with regulatory standards (FDA, ICH, EMA). 

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  Work cross-functionally with clinical, manufacturing, and non-clinical teams to ensure alignment between regulatory and quality efforts and corporate goals. 

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  Manage and lead the regulatory and quality teams, ensuring cohesive execution of regulatory and quality strategies. 

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  Stay current with evolving regulatory requirements and provide guidance on regulatory and quality compliance, particularly in oncology and obesity. 

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  Contribute to the development of corporate strategy, ensuring regulatory and quality perspectives are integrated into decision-making processes. 

What You’ll Bring to Our Team:

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  A people-first mindset with a collaborative approach to problem-solving. 

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  Strong leadership skills with the ability to manage regulatory and quality functions in a fast-paced, dynamic environment. 

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  10+ years of regulatory experience in the pharmaceutical or biotechnology industry, with a focus on small molecules. 

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  Proven success managing regulatory interactions with FDA, EMA, and other global health authorities. 

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  Experience overseeing quality systems in a regulatory capacity, with strong understanding of compliance standards (FDA, ICH, EMA). 

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  Demonstrated success in regulatory submissions, including IND, NDA, and MAA filings. 

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  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

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  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. 

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  A data-driven approach to decision-making, seeking regulatory insights from multiple sources, and aligning the regulatory and quality strategy with corporate goals. 

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  An entrepreneurial mindset that encourages innovation within the regulatory framework, exploring novel regulatory pathways such as accelerated approvals and combination development strategies. 

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  The ability to balance ambitious strategic objectives with regulatory realities, creating realistic and actionable implementation plans that ensure compliance while driving innovation. 

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  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). 

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  Ability to manage ambiguity, adapt nimbly to regulatory changes, and lead the organization through complex regulatory environments and shifting quality standards. 

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  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. 

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  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. 

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  Skilled in attracting, recruiting, and developing top regulatory and quality talent, delegating responsibilities effectively while fostering a culture of continuous improvement. 

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  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. 

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  Self-reflective and aware of personal limitations, driving organizational performance by leading with humility, being open to feedback, and continuously seeking self-improvement. 

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  Builds strong relationships across regulatory agencies, internal teams, and external partners, demonstrating high emotional intelligence and persuasive communication skills. 

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  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. 

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  Shares the spotlight with team members, celebrating both individual and team successes, and fostering a collaborative culture across departments. 

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  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.