Director of Regulatory Operations

The Opportunity:

The Director of Regulatory Operations will be responsible for developing and scaling a regulatory infrastructure that supports growth and increased portfolio complexity. This position offers the opportunity to build upon an established team and function by implementing the systems, processes, and practices required for long-term scalability and compliance. Reporting to the Senior Director of Regulatory Operations, this individual will support the strategic direction of Regulatory Operations, conduct a thorough analysis of current capabilities, and manage the development and implementation of operational improvements. The role will also provide mentorship to a capable team currently managing health authority submissions and ready for expanded responsibilities. Success in this role requires the ability to execute while building, work effectively in a dynamic and highly collaborative environment, and remain flexible and adaptive as priorities evolve.

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  Define strategic plans and ensure efficient operational execution with leadership to support increasing submission volume, expansion, and company growth.
  
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  Communicate complex regulatory and operational issues clearly, providing solutions that balance compliance with the demands of scale.
  
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  Advance cross-functional initiatives that enhance the department’s strategic impact and operational effectiveness and provide value to the overall positioning of the department
  
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  Translate business needs into scalable, well-documented regulatory systems and process configurations.
  
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  Drive the development, optimization, and implementation of procedures, training, and documentation to support compliant and efficient submission operations.
  
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  Provide oversight for teams responsible for planning, preparing, publishing, submitting, and archiving global regulatory dossiers.
  
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  Mentor a team towards exceptional performance, while coordinating with external vendors to ensure timely, high-quality regulatory publishing.
  
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  Support the system owner and administrator for regulatory technologies (e.g., Veeva Vault RIM); manage implementations, upgrades, and change management activities.
  
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  Champion the adoption of innovative tools and technologies to improve submission operations, regulatory compliance, and organizational scalability cross-functionally.
  

Required Skills, Experience and Education:

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  Proven leadership in developing and executing regulatory operations strategy within global biotech or biopharma organizations.
  
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  Deep expertise in submission planning, global regulatory frameworks, eCTD standards, and Health Authority requirements.
  
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  Advanced experience managing and configuring regulatory systems, particularly Veeva Vault RIM.
  
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  Strong project management skills, with the ability to oversee multiple priorities and deliver results in a dynamic environment.
  
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  Clear and persuasive communicator across technical and business stakeholders.
  
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  Effective collaborator with the ability to influence and align cross-functional teams.
  
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  Strategic thinker with a practical problem-solving mindset and long-term business orientation.
  
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  Committed to developing high-performing teams and fostering a culture of accountability and continuous improvement.
  
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  Experience leading process improvement and system optimization initiatives in a compliance-focused environment.
  

Preferred Skills:

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  Seasoned people manager.
  
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  Adept in regulatory publishing; capable of serving as a backup publisher.
  
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  Proficient in Smartsheet for project tracking and collaboration.
  
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  Proficient in Lorenz DocuBridge.
  
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  Extensive hands-on experience with Veeva RIM system management.