Sr. Director, RA



 We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

 Job Description We are the makers of possible ! BD is one of the largest global medical technology companies in the world. Advancing the world of health ™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. The Sr. Regulatory Affairs (RA) Director i s responsible for the management , leadership, and setting the direction for multiple product franchises or a business platform , including management of regulatory professionals within those franchises . The Sr. Director is responsible for developing and implementing regulatory strategies and submissions in support of global marketing within their respective platform . The Sr. Director determines priorities and overall structure for their platform and defines and manages expectations for projects . The Sr. Director will work with external contacts , with US and international regulatory authorities, physician advisors, and key industry specialists as related to their product platform . The Director of RA must be k nowledgeable about current and possible future policies, practices, trends, technology and information affecting the business and organization. Responsibilities: Manages and directs work for one or more RA P latforms or critical programs , including multiple product franchises and associated product lines . Provides regulatory leadership for respective RA business p latform(s) or RA program (s ) and manages individua ls and people managers working on RA projects or teams within that platform . Recruits, develops, and manages RA professionals with higher levels of seniority, experience, and skills, and ensures regulatory milestones assigned to direct reports are met. Responsible for the overall management of RA Professionals within the respective platform, and structures projects and managers appropriately to ensure work is completed efficiently and effectively . Develops managers and technical leaders by making accurate assessments of individuals’ capabilities and performance, and provides feedback, coaching, guidance and mentoring. Manages and directs budget related to Platform(s) and/or projects, including submission costs, travel, and training for teammates. Partners proactively in the product development process to provide strategic guidance for development planning from the exploratory phases for new products through the ongoing compliance phases for commercialized products. Represents Regulatory in Business Unit and Business Segment meetings . Understands and anticipates detailed Regulatory expectations for approval, including precedence and changes in the regulatory landscape . Manages communications and negotiates with regulatory agencies on behalf of the business, as they pertain to regulatory decisions and strategies. Critically assesses impact of studies and data on project outcome and works with Senior Leadership to determine project strategy. Influences all parties to ensure successful submission outcomes, including submission content management. Coordinates with Quality function on recall strategies and responses to quality audit findings.