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.
- 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.