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Manager - Regulatory Affairs - Therapeutic Area

Employer
Novo Nordisk
Location
Plainsboro, NJ
Start date
May 29, 2024

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Discipline
Regulatory, Regulatory Affairs
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Best Places to Work

Job Details

About the Department                                                                                                                                               

The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk 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

Manage and oversee all assigned projects/products/processes. Assist the Director/Associate 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. Supervise designated personnel.

 

Relationships

Report to the Director/Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory Affairs. Develop and maintain positive rapport and working relationships with other personnel in Regulatory Affairs, CMR, and other local and headquarter departments to accomplish company goals. External relationships may include interaction with FDA personnel regarding assigned projects and roles.

 

Essential Functions

  • Compile and submit responses to FDA communications. MANAGER, THERAPEUTIC AREA: Compile, submit and maintain applications (IND, NDA, Biologics, Devices) to government agencies in support of research and marketed products
  • Create and maintain product/project database to record history of questions asked / responses received during FDA meetings
  • Liaison between Novo Nordisk Inc. (NNI) and NNAS departments for preparation of documentation necessary for submission of applications
  • Maintain meeting documentation templates and ensure they are current with FDA guidances and Novo Nordisk standards
  • Maintain up-to-date knowledge of laws, regulations and policies enforced by the Federal and State governments as they relate to pharmaceuticals and devices
  • Maintain up-to-date knowledge of the data, information, and formats required for inclusion in these applications
  • Manages simple development projects or portions of projects
  • May act as FDA liaison for routine contacts and handles finalization of routine correspondence
  • May act as GRT member
  • Oversight of annual reports
  • Participate in project team meetings as assigned
  • Review data from contributing departments (including NNAS) and provide comments to assure accurate and complete documents for inclusion in these applications
  • Review of regulatory strategy documents; e.g., provides supervisor with input on regulatory strategy documents
  • Supervise, review and approval of labeling for marketed products
  • Track applications through FDA reviewing divisions
  • Work with project associate on compilation of information and supportive documentation for FDA briefing packages
  • Work with project leader and team to draft FDA meeting requests and supporting briefing packages for FDA meetings (pre-IND, EOP 2, pre-NDA, pre-BLA) for review by Project Leaders
  • Write Regulatory documents translating team strategy into regulatory overview documents such as cover letters, pre-meeting package, and other US specific regulatory positioning documents to assist Project Leaders in support of business needs
  •  

    Physical Requirements

    0-10% overnight travel required.

     

    Qualifications

  • A Bachelors degree required; Life Science and advanced degree preferred
  • A minimum of 4 years of progressively responsible related experience; including hands on related pharmaceutical or medical device/pharmaceutical combination product experience and actual regulatory experience   
  • Advanced knowledge of pertinent FDA regulations
  • Detail & deadline oriented; well organized
  • Excellent verbal & written communication skills
  • Experience leading projects in specific regulatory area preferred
  • Good interpersonal skills; ability to interact with staff on all levels
  • Knowledge of diabetes and diabetes management beneficial
  • Previous supervisory/management experience advantageous
  • Works independently with minimal supervision
  • Previous hands on experience with compilation and filing of INDs/NDAs/Amendments/Supplements
  •  

    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.

    Company

    Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 54,400 people in 80 countries and markets its products in around 170 countries. For more information visit novonordisk.com.

    Our US Research & Development hub, located in the Greater Boston area, brings together the best talent to drive life science innovation. Located in Lexington, Watertown and Cambridge, our teams reflect the full scope of R&D, from early research through late-stage clinical development. We are building for the future by 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. By combining the speed and agility of biotech with the quality, resources, and stability of a large pharmaceutical company, our US R&D hub will benefit from the best of both worlds to develop new medicines that meet the needs of patients.

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    Company info
    Website
    Phone
    617-612-6200
    Location
    75 Hayden Avenue
    Lexington
    MA
    02421
    United States

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