About the Department

　　The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk (NN) is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient-centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We’re changing lives for a living. Are you ready to make a difference?

　　The Position

　　Oversee all assigned projects/products/processes. Assist the Senior Director in assuring Novo Nordisk compliance with internal SOPs and Federal and State regulations, including compilation and submission of any required documents to regulatory agencies. Act as liaison with FDA for assigned projects. The position is in the Rare Disease group that is handling projects and products within rare bleeding disorders, rare blood disorders, and rare endocrine disorders.

　　Relationships

　　Report to the Senior Director Regulatory Affairs. Interact with key company personnel both within and outside of Novo Nordisk-US as related to assigned projects. Develop and maintain positive rapport and working relationships with other personnel in Regulatory Affairs, CMR, and other local and headquarter departments in support of initiatives and to accomplish company goals. FDA liaison for designated projects or as requested by supervisor.

　　Essential Functions

　　Act as liaison with NNI and NN headquarter departments for preparation of documentation necessary for submission of applications

　　Review data from contributing departments (including NN headquarter) and provide comments to assure accurate and complete documents for inclusion in these applications

　　Assist senior Regulatory Affairs personnel in assuring compliance

　　Coordinate and supervise the development of regulatory strategies for new or modified pharmaceutical products and 510(k) devices for assigned projects/products

　　Plan FDA submissions for assigned products/projects to ensure efficient use of resources

　　Facilitate and organize the compilation of applications (INDs, NDAs, BLAs, Devices) to government agencies for assigned projects/products

　　Maintain up-to-date knowledge of data, information, and formats required for inclusion in applications

　　Serve as the FDA liaison on all matters for assigned products/projects

　　Identify the need for and provide input into the development of systems for the efficient operation of the department

　　Lead FDA meetings and major label negotiations

　　Provide information and training for NN headquarter in areas of IND, NDA, and 501(k) processes

　　Disseminate information on FDA regulations and guidelines for products/projects

　　Provide input into development of SOPs for the efficient operation of the department and inter-department activities

　　Provide training to the regulatory staff and Sales Reps as needed

　　Responsible for development of regulatory submission strategies

　　Physical Requirements

　　Up to 10% overnight travel required.

　　Qualifications

　　Bachelor's degree required; Advanced degree in Life Science preferred

　　Minimum of 8 years of pharmaceutical/related industry experience required

　　Familiarity with FDA regulations and project management experience required

　　Prior exposure to other key regulatory authorities (e.g. EMEA, EU national authorities, PMDA) preferred for global projects

　　Expertise within the rare disease area and gene therapy would be preferred.

　　Detail & deadline-oriented; well-organized

　　Ability to work independently and establish working relationships across local and global teams

　　Excellent verbal and written communication skills essential

　　Good interpersonal skills; ability to interact with staff on all levels

　　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 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.