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Vice President / Global Head, Regulatory Affairs

Cardurion
Burlington, MA Full Time
POSTED ON 3/9/2025
AVAILABLE BEFORE 6/4/2025

Vice President / Global Head, Regulatory Affairs

Join to apply for the Vice President / Global Head, Regulatory Affairs role at Cardurion Pharmaceuticals

This role is either Hybrid in Burlington, MA or Remote.

Why join Cardurion Pharma?

We are a clinical-stage biotechnology company discovering and developing new therapeutic approaches to treat cardiovascular disease. We invite you to explore our website to learn more about our Company and how we are advancing towards our goal of building a world-class biotechnology company that discovers, develops and commercializes life-changing therapeutics for patients with cardiovascular disease.

The Role

The VP, Global Head of Regulatory Affairs will be a key member of the R&D leadership team, responsible for leading the global regulatory organization. They will oversee and be accountable for the following functions : Regulatory Strategy, CMC Regulatory Affairs, and Regulatory Operations.

Here's What You'll Do :

  • A key member of the R&D leadership team, responsible for overseeing leadership of the global regulatory organization.
  • Oversee and be accountable for growing and leading a regulatory organization inclusive of the following functions : Regulatory Strategy, CMC Regulatory Affairs, and Regulatory Operations.
  • Works with program team members to establish regulatory strategies for development programs and provides insight and direction to the Business Development function.
  • Proactively identifies potential strategic issues / opportunities and communicates potential risks associated with strategic scenarios.
  • Oversees and / or leads both clinical and CMC related regulatory agency interactions.
  • Monitors US, EU and Global regulations, and assesses any changes to ensure all development activities are in compliance with applicable current regulations and guidelines.
  • Develops strategies for complex issues with potential for significant regulatory compliance impact.
  • Builds mutually respectful and collaborative working relationships with other key functions and motivates the group to the highest level of performance and quality.
  • Able to hold people accountable, provide thoughtful and accurate feedback; delegate appropriately, drive to develop and retain top talent.
  • Builds relationships and leads a cross-functional team through influence.
  • Adapts quickly to changing conditions and is a calming leader to their group in times of uncertainty.
  • Serves as the single point of contact for all regulatory interactions and remains current on all active programs.
  • Establishes clear responsibilities and processes for monitoring work and measuring results.
  • Actively seeks input from pertinent sources to make timely and well-informed decisions.

Here's What We'll Bring To The Table :

  • Highly competitive benefits including : medical offered through BCBS PPO, Delta Dental, and vision offered through VSP.
  • Fully funded HSA for high-deductible PPO Plan.
  • Flexible Spending Accounts for medical expenses and dependent care expenses.
  • 4 weeks Paid Time Off annually.
  • 10 company paid holidays and Year-End shut down.
  • 401k (traditional and Roth offered) with 100% match on first 4% deferred. Match is vested immediately.
  • A suite of Cardurion paid insurance coverage, including : life insurance, short-term and long-term disability.

    • Our Mission

    Translate our world-class expertise in cardiovascular signaling pathways into potentially groundbreaking therapeutics for patients.

    Requirements :

  • Minimum of a Bachelor's Degree in relevant area of study with an advanced degree preferred.
  • 15 years of experience in Global Regulatory Affairs, with a significant focus in cardiovascular diseases.
  • An experienced leader who has successfully worked in high performance cross-functional teams.
  • Demonstrates managerial courage to lead teams through change.
  • Experience interfacing with regulatory agencies, thorough knowledge and understanding of regulatory requirements.
  • Excellent verbal and written communication skills and collaborative interpersonal skills.
  • Strategic mindset with the ability to anticipate future trends accurately.
  • Sets aggressive but achievable goals and has high standards.
  • Lead and inspire the Regulatory Team to achieve strategic goals.

    • Seniority level

    Executive

    Employment type

    Full-time

    Job function

    Legal

    Cardurion is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants.

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