Manager - Regulatory Affairs - Therapeutic Area

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