Associate Director - Global Regulatory Lead

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Job description

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 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

You will report to the Senior Director - Global Regulatory Portfolio Lead.

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 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 managing timelines while working in a fast-paced and dynamic environment across both time zones and cultures

Physical Requirements

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

Qualifications

A Bachelors required/Advance degree preferred

Minimum of 8 years total pharmaceutical/related industry experience in drug development required

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 Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

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