Vice President, Regulatory Operations & Compliance

My client is a clinical-stage company committed to developing potentially transformative gene therapies for severe genetic and rare diseases.  Based on their ongoing growth, they have created a new position for a Vice President of Regulatory Operations & Compliance. They are seeking a senior Regulatory Operations leader who can establish a long-term team strategy and build a high-performing global team.  You will work closely with senior-level company executives to develop a strategic, global roadmap and help steer the company towards success. This is an exciting opportunity to leverage your knowledge and expertise to lead key cross-functional initiatives while overseeing multiple complex filings globally.

Responsibilities:

  • Lead the Regulatory Operations and Compliance (ROC) function and enable successful product development, approvals and life-cycle management.
  • Establish the long-term strategy for the ROC team, activities and planning in accordance with established road-map and with an expectation to scale-up efficiently and rapidly.
  • Provide strong cross-functional leadership for complex global filings, and to support the growth of the Regulatory Science department in a fast-paced environment in partnership with the Information Technology, Portfolio and Project Management and Quality functions.
  • Build and maintain strong leadership capabilities at all levels within the ROC team and support the professional development of ROC team members.
  • Ensure the successful on time delivery of high-quality submissions to global regulatory health authorities in alignment with both bluebird bio and health authorities standards.
  • Oversee the development and implementation of innovative systems, tools and streamlined processes to create and maintain high-quality regulatory submissions and manage a state-of-the-art regulatory intelligence and knowledge management approach.
  • Responsible for continuous improvement of systems and processes, including internal training, for Regulatory Science department
  • Partner with the Portfolio and Project Management function in supporting effective planning for global regulatory activities, including major complex submissions
  • Oversee Inspection Readiness efforts for Regulatory Science
  • Oversees Regulatory Science budgets and Vendor Management activities
  • Participate actively in the Regulatory Science Leadership Team
  • Maintain familiarity with current regulatory operations trends
  • Participate as needed in technical discussions and collaborate with corresponding groups at Health Authorities to advance Regulatory Science

 

Knowledge & Skills:

  • Bachelor’s degree required, Master’s degree preferred.
  • Minimum 10 years in the biopharmaceutical industry (ideally both mid-size and large companies) with a focus on Regulatory Operations.
  • Extensive Regulatory Operations management experience and success in fostering effective team spirit and in developing innovative Regulatory Operations and Compliance solutions.
  • Broad conceptual and practical experience to solve complex problems.
  • Extensive experience in RIMS including the selection and implementation of electronic document management systems.
  • Knowledge expert regarding global regulatory submission standards, software validation concepts, and publishing best practices.
  • Experience with process design and improvement and with developing systems from the ground up.
  • Excellent cross-functional leadership and project management skills.
  • Independently motivated, excel at driving execution, detail oriented and good problem-solving ability.
  • Strong organizational skills to multi-task in an extremely fast-paced environment with changing priorities.
  • Ensures timely issue identification, resolution, and implementation.

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