VP, Regulatory Operations and Compliance (ROC)

Location
Cambridge, MA, United States
Posted
Nov 28, 2018
Ref
1421408
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Join bluebird bio's enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. As the leader of the Regulatory Operations and Compliance (ROC) function, you will be responsible for building a high-performing ROC function and overseeing submissions management activities, design and implementation of regulatory systems and tools, regulatory project management and compliance. In this role, you will be responsible for setting the long-term strategy and vision for the ROC function, creating and executing ROC strategies, and collaborating with Regulatory Science leadership to set goals, drive process efficiencies and overall operational effectiveness for global regulatory submissions.

As a senior leader within bluebird, the candidate will leverage broad knowledge and expertise to lead key cross-functional initiatives, including multiple complex filings globally. The candidate will take a company-wide approach to problem solving and provide bluebird colleagues with the information and innovative tools required to prepare successful and high-quality regulatory submissions, creating a seamless environment for all stakeholders. You will play a key role in anticipating future needs for the Regulatory Science teams to support rapid and global growth.

Make your mark by building a world-class Regulatory Operations and Compliance department in a fast-growing organization with an aspiration to transform the lives of patients.

About the role:
  • Lead the Regulatory Operations and Compliance 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

About you:
  • Bachelor's degree required, Master's degree preferred.
  • Minimum 10 years in biopharmaceutical industry (ideally both mid-size and large companies) with 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 selecting 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.
  • Proactive, collaborative (one team), efficient, clear and open working style
  • Ownership mindset
  • Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself