Requisition ID 17435BR
Title Manager/Sr. Manager, Regulatory Affairs - Regulatory Intelligence
Job Category Regulatory Affairs
Job Description PURPOSE:
Manage Regulatory Intelligence and Registration Information Management System (RIMS) support for the Regulatory Affairs department. Proactively monitor the US regulatory environment, identify and analyze information pertinent to Novo Nordisk, and communicate such information to stakeholders. Ensure that RIMS activities for Regulatory Affairs are carried out according to established procedures. Contribute to additional Regulatory Intelligence and RIMS projects as needed. Assist Regulatory Affairs Management in assuring Novo Nordisk compliance with internal SOPs and Federal and State regulations.
RELATIONSHIPS:
Reports to Regulatory Operations and Innovation management. Works with personnel in other departments including Marketing, CMR, Legal, as well as counterparts in NN/AS Regulatory Affairs and the RA Global Services Center (GSC) in Bangalore. Works closely with RA Therapeutic Area (TA) team members on Regulatory Intelligence and RIMS activities. A positive approach to projects and willingness to maintain constructive and positive interactions with coworkers is necessary.
ESSENTIAL FUNCTIONS:
• Assist supervisor in the coordination of information flow from and to pharmaceutical organizations such as PhRMA, BIO and AdvaMed to promote Novo Nordisk positions in relation to regulatory environment.
• Explore internal and external regulatory intelligence for the preparation and submission of regulatory documents, assuring NNI compliance with Federal and State Regulations and tracking submission status for corporate database.
• Identify and analyze relevant external intelligence sources e.g. FDA, HHS, PHRMA, US Government, NN Project intraweb, competitor website, and industry publications. Provide summaries of information to product/project teams.
• Maintain surveillance of regulatory environment and competitor development and provide evaluation to product/project teams.
• Maintain up-to-date general knowledge of FDA guidances and regulations to facilitate collection and evaluation of ongoing regulatory climate.
• Monitor and evaluate regulatory landscape e.g. Federal, State, HHS, FDA communications/rules/guidelines for information pertinent to Novo Nordisk business.
• Publish and disseminate intelligence (weekly Highlights or summary of pertinent articles) in a timely manner, to relevant groups within RA/CMR, NN-US (e.g. Legal, Marketing, Sales) or Headquarters.
• Manage collection of research, analyze information, and compose letters on Novo Nordisk opinions/position on FDA draft guidances, proposed rules etc. to provide comments on regulatory initiatives.
• Manage input of submission information into Regulatory Information Management System (RIMS) through RA Global Services Center (GSC), provide required data to Headquarters and GSC, and ensure that all US data in RIMS is complete, correct and handled within required timelines.
• Collaborate with Regulatory Affairs TA to ensure that RIMS data are specifically aligned with FDA submissions.
• Work with colleagues in HQ and GSC on projects and initiatives supporting RIMS activities.
• Provide RIMS training to Regulatory Affairs department.
• Assist with overflow in other areas as needed and handle other duties and/or special projects as assigned by Regulatory Affairs management.
PHYSICAL REQUIREMENTS:
• Approximately 10% overnight travel
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
• A BA/BS required (life science or related area); advanced degree preferred
• A minimum of 6 years related regulatory affairs experience required
• Advanced knowledge of pertinent FDA regulations
• Experience with regulatory intelligence activities and pharmaceutical registration databases is preferred
• Detail & deadline oriented; well organized
• Excellent verbal & written communication skills
• 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
• An advanced proficiency in Microsoft Office Suite required
• Effective personal time management and project management skills
Department CMR - REG AFFAIRS (5a)
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 0 - 10%
Title Manager/Sr. Manager, Regulatory Affairs - Regulatory Intelligence
Job Category Regulatory Affairs
Job Description PURPOSE:
Manage Regulatory Intelligence and Registration Information Management System (RIMS) support for the Regulatory Affairs department. Proactively monitor the US regulatory environment, identify and analyze information pertinent to Novo Nordisk, and communicate such information to stakeholders. Ensure that RIMS activities for Regulatory Affairs are carried out according to established procedures. Contribute to additional Regulatory Intelligence and RIMS projects as needed. Assist Regulatory Affairs Management in assuring Novo Nordisk compliance with internal SOPs and Federal and State regulations.
RELATIONSHIPS:
Reports to Regulatory Operations and Innovation management. Works with personnel in other departments including Marketing, CMR, Legal, as well as counterparts in NN/AS Regulatory Affairs and the RA Global Services Center (GSC) in Bangalore. Works closely with RA Therapeutic Area (TA) team members on Regulatory Intelligence and RIMS activities. A positive approach to projects and willingness to maintain constructive and positive interactions with coworkers is necessary.
ESSENTIAL FUNCTIONS:
• Assist supervisor in the coordination of information flow from and to pharmaceutical organizations such as PhRMA, BIO and AdvaMed to promote Novo Nordisk positions in relation to regulatory environment.
• Explore internal and external regulatory intelligence for the preparation and submission of regulatory documents, assuring NNI compliance with Federal and State Regulations and tracking submission status for corporate database.
• Identify and analyze relevant external intelligence sources e.g. FDA, HHS, PHRMA, US Government, NN Project intraweb, competitor website, and industry publications. Provide summaries of information to product/project teams.
• Maintain surveillance of regulatory environment and competitor development and provide evaluation to product/project teams.
• Maintain up-to-date general knowledge of FDA guidances and regulations to facilitate collection and evaluation of ongoing regulatory climate.
• Monitor and evaluate regulatory landscape e.g. Federal, State, HHS, FDA communications/rules/guidelines for information pertinent to Novo Nordisk business.
• Publish and disseminate intelligence (weekly Highlights or summary of pertinent articles) in a timely manner, to relevant groups within RA/CMR, NN-US (e.g. Legal, Marketing, Sales) or Headquarters.
• Manage collection of research, analyze information, and compose letters on Novo Nordisk opinions/position on FDA draft guidances, proposed rules etc. to provide comments on regulatory initiatives.
• Manage input of submission information into Regulatory Information Management System (RIMS) through RA Global Services Center (GSC), provide required data to Headquarters and GSC, and ensure that all US data in RIMS is complete, correct and handled within required timelines.
• Collaborate with Regulatory Affairs TA to ensure that RIMS data are specifically aligned with FDA submissions.
• Work with colleagues in HQ and GSC on projects and initiatives supporting RIMS activities.
• Provide RIMS training to Regulatory Affairs department.
• Assist with overflow in other areas as needed and handle other duties and/or special projects as assigned by Regulatory Affairs management.
PHYSICAL REQUIREMENTS:
• Approximately 10% overnight travel
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
• A BA/BS required (life science or related area); advanced degree preferred
• A minimum of 6 years related regulatory affairs experience required
• Advanced knowledge of pertinent FDA regulations
• Experience with regulatory intelligence activities and pharmaceutical registration databases is preferred
• Detail & deadline oriented; well organized
• Excellent verbal & written communication skills
• 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
• An advanced proficiency in Microsoft Office Suite required
• Effective personal time management and project management skills
Department CMR - REG AFFAIRS (5a)
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 0 - 10%