Director - Global Regulatory Lead

About the Department                                                                                                                                             

Our Boston Research & Development hub, anchored in the greater Boston area, brings together the best minds in life science innovation. The teams located in facilities in Lexington, Watertown and Cambridge reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on us. Our greater Boston R&D 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.

 

The Position

We are seeking a collaborative and science-driven global regulatory expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute regulatory strategies for high impact projects while working with decision-makers across multiple functional areas.

 

Relationships

This role will work with the team both in the US and Denmark.

 

Essential Functions

• Serve as a member of the Global Project Team (GPT) utilizing precedent and experience to develop innovative and flexible approaches to achieve development goals, advise on development strategies, and deliver on associated regulatory activities
• Lead the Global Regulatory Matrixed Team in defining and executing the global regulatory strategy for assigned programs to ensure timely and high-quality regulatory deliverables to the GPTs
• Lead health authority interactions, including leading team through creation of briefing materials and meeting preparation
• Lead and/or support global filing activities for submissions
• Present regulatory strategies including communication of regulatory risks and associated mitigation plans to management and other internal stakeholders
• Perform or supervise 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.
• Research and analyze the evolving competitive and regulatory landscapes to maintain current knowledge
• Effectively manage timelines while working in a fast-paced and dynamic environment across both time zones and cultures

 

Physical Requirements

This position is based in Lexington, MA.  Hybrid schedule of 3 days in the office is preferred; remote candidates may apply. 

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, procedures, and Novo Nordisk Way.

 

Qualifications

• A Bachelor’s degree in a scientific discipline is required/an advanced degree is strongly preferred
• Minimum of 10 years drug development/FDA/regulatory related industry experience required
• Cell/gene therapy experience preferred
• Demonstrated knowledge of global regulatory requirements for drugs and biologics
• Proven ability to develop robust regulatory strategies required
• Experience interacting directly with regulatory authorities on an international scale
• Experience preparing teams for and leading meetings with regulatory agencies, including the FDA
• Experience with rare disease drug development, innovative trial design and/or expedited regulatory pathways, highly desired
• Experience in setting direction for, leading, and motivating a team to work for joint objectives
• Excellent verbal and written communication skills
• Strong organizational and demonstrated problem-solving capabilities
• Ability to thrive in a busy environment and maintain a positive attitude under pressure

 

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

 

At Novo Nordis