Senior Director - Global Regulatory Portfolio Lead

About the Department                                                                                                                                    

Our East Coast Global Development Hub brings together the best minds in life science innovation with facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple innovative modalities and therapeutic areas. Our East Coast Global Development Hub merges biotech speed and agility with large pharmaceutical company quality, resources, and stability, uniting the best of both worlds to develop new medicines for patients. We recognize that improving human health starts here and that patients rely on us. We’re changing lives for a living. Are you ready to make a difference?

 

The Position

We are seeking a Senior Director, Global Regulatory Portfolio Lead who will be responsible for developing, implementing, and advising on global regulatory strategies for assigned programs to ensure efficient development and to secure and maintain registrations in line with business objectives. As a leader in the department, he/she will also manage and mentor global regulatory leads (GRLs) and other regulatory staff, as well as support/lead development and implementation of department policies. The Senior Director may also serve as a GRL on a global project team on an as needed basis.

 

Relationships

Reports to the VP, Regulatory, Quality & Clinical Reporting, East Coast Global Development Hub.

 

Essential Functions

• Recruits, develops and provides leadership to GRLs and other regulatory team members via direct and indirect reporting structures to ensure innovative and robust global regulatory strategies are developed and documented to maximize regulatory success and minimize time to approval
• Develops best practices and creates a strong sense of regulatory community across the East Coast Global Development Hub, including colleagues in Lexington, MA and Princeton, NJ, as well as the broader Global Regulatory Affairs (GRA) organization
• Serves as an influential leader within Novo Nordisk by building a strong cross-functional network and contributing to cross-functional initiatives to ensure that strategic business goals are met through the sharing of knowledge and expertise
• Liaises and negotiates with global regulatory authorities, including FDA and EMA, for all aspects pertaining to drug development, approval, and labeling changes
• Maintains current knowledge of the competitive landscape and global regulatory environment. Assesses and communicates the impact of changes on product development programs and facilitates the interpretation of global regulatory guidance and regulations. Helps to influence the external landscape, where applicable
• Provides strategic regulatory direction and leadership on projects including, but not limited to, global regulatory development strategies and risk assessments, regulatory requirements for clinical studies and marketing approval in global markets, critical issue management, and advice on Health Authority interactions
• May serve as a member of Global Project Teams (GPTs) utilizing precedent and experience to develop innovative and flexible approaches to achieve development goals, advise on development strategies, and deliver on associated regulatory activities
• Performs or supervises regulatory review of all clinical and nonclinical documents for submissions, e.g., clinical protocols and study reports, preclinical reports, investigator brochures, application summary documents, etc.
• Presents regulatory strategies including communication of regulatory risks and associated mitigation plans to senior management and other internal stakeholders
• Effectively works in a fast-paced and dynamic environment across both time zones and cultures while maintaining a positive attitude

 

Physical Requirements

10-20% overnight travel required. Ability to lift 0-10 lbs.

 

Development of People

Ensure that reporting personnel have individual development plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process.

 

Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.

 

Manage the application and communication of all Novo Nordisk policies, proc