- Therapeutic Area:
- Assist Manager/Director in review of labeling for marketed products and new products as assigned
- Maintain up-to-date knowledge of data requirements and formats, applicable current SOPs, regulations, and guidelines, and proactively provides guidance to ROI staff as needed during assembly of regulatory submissions
- Draft more complex correspondence
- Draft ROCs for more complex contacts
- Prepare routine correspondence
- Provide proactive support and technical assistance during preparation and review of regulatory documents
- As assigned, participate in project teams
- Assist with technical preparation for FDA meetings, including review of draft questions and supporting documents
- Assume additional responsibilities as applicable
- Complete internet searches
- Proactively manage the scope of project responsibilities, identify and compose draft correspondence relevant to projects on own initiative, such as letters of response, transmittal and memoranda where applicable. Use and contribute to development of templated correspondence as appropriate, ensuring that all new information is correct
- Proactively seek and find information/potential answers to challenging areas related to assigned projects in the interest of keeping the project streamlined and moving forward
- Provide proactive support in managing project
- Take the initiative to assist with overflow in other areas as needed
- Advise stakeholders of submission completion
- Compile applications and prepare for sign-off (INDs/NDAs/BLAs/510ks, IND amendments & Annual Progress Reports, NDA Annual Reports & Annual ADE Reports, IND Safety Reports, Drug & Establishment Listings, responses to FDA communications, among others as assigned), assure submission to government agencies in support of investigational and marketed products is completed in accordance with supervisors requirements and guidance
- Coordinate review of documents and follows up to resolve issues
- Obtain documents/information for regulatory submissions from various functional areas and checks for errors, missing information, legibility, translations, etc.
- Proactively coordinate document submission
- Proactively identify issues and inform appropriate individuals
- Review information from local & NNAS contributing departments and provide comments to assure that documents are accurate and complete and comply with FDA regulations
- Works with manager to gather internal intelligence including tracking and maintaining the Submissions Plan update. Consolidates research and gathers Novo Nordisk opinions/position (e.g. FDA draft guidances, proposed rules). Works with manager to compose letters incorporating NN position on external regulatory initiatives
- Works with Group Manager to maintain surveillance of regulatory environment and competitor development
- Evaluates submission information for input into Regulatory Information Management System (RIMS) within required timelines
- Responsible for maintenance reports notification for all projects/products Quarterly and Annual Safety Updates. Works with Labeling group to ensure timely completion of labeling tasks and assignments
- Participates in department forum meetings e.g. CMC, PRB, and ensures that proper minutes from these meetings are available in the database. Assists with overflow in other areas as needed and handle other duties and/or special projects as assigned by Regulatory Management
- A Bachelor 's Degree required; Life Science preferred
- A minimum of 5 years' experience required (Pharmaceutical industry, laboratory, or clinical research experience)
- An intermediate to advanced proficiency in Microsoft Office Suite required
- Attention to detail and skill in reviewing to ensure accuracy
- Effective personal time management and project management skills
- Excellent written, verbal and listening communication skills
- Focuses on streamlining of processes to add value
- The ability to work with less direct supervision than at Associate level
- Willingness and ability to identify and implement action plans independently
-
Specialist - Regulatory Affairs
1 week ago
Novo Nordisk Plainsboro, United States**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 ...
-
Specialist - Regulatory Affairs
1 week ago
Novo Nordisk A/S Plainsboro, United StatesProvide proactive support and technical assistance to more experienced regulatory personnel. Identify issues and inform appropriate individuals. Ability to work with less supervision than Associate. Take initiative to assist with overflow in other ar Regulatory Affairs, Regulator ...
-
Specialist - Regulatory Affairs
4 days ago
Novo Nordisk Plainsboro, United StatesAbout 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 ...
-
Specialist - Regulatory Affairs
4 days ago
Novo Nordisk Plainsboro, United StatesAbout the DepartmentThe 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 prov ...
-
director regulatory affairs
5 days ago
TK-CHAIN LLC Princeton, United StatesSUMMARY OF POSITION The Director, Regulatory Affairs integrates and applies knowledge of US regulatory guidelines and federal regulations governing pharmaceutical drug development to all aspects of Our Client's 's drug development programs, policies and procedures; ensuring a com ...
-
Director of Regulatory Affairs
2 weeks ago
BioPhase Princeton, United StatesHybrid - 3 days a week in office - Princeton, NJ · The Associate Director of Regulatory Affairs Labeling will assist in the development of a cross-functional labeling strategy for products worldwide, including providing expert input on labeling requirements and strategic guidanc ...
-
Regulatory Affairs Associate
1 week ago
Laboratoire Guerbet Princeton, United StatesAt Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose. · We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional ...
-
Regulatory Affairs Analyst
1 week ago
Freyr Princeton, United StatesRegulatory Affairs Analyst (Master's or equiv. degree w/1 yr. exp.) Princeton, NJ. Exp. in: manage & coordinate regulatory affairs team; implement regulations for preparation & submission of regulatory documentation; risk management planning & traceability matrix; submitting docu ...
-
Regulatory Affairs Associate
4 days ago
Laboratoire Guerbet Princeton, United StatesAt Guerbet, we build lasting relationships so that to enable people to live better . This is · Our Purpose. · We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventio ...
-
Senior Regulatory Affairs
1 week ago
Diverse Lynx Princeton, United StatesHi, · Welcome to Diverse Lynx We combine industry leading expertise and our personal dedication to help you find your next career opportunity. We are a Minority and Women Owned Business Enterprise (MWBE) certified by the State of New Jersey and Minority Business Enterprise (MBE) ...
-
director regulatory affairs
4 days ago
TK-CHAIN LLC Princeton, United StatesJob Description · Job DescriptionSUMMARY OF POSITION · The Director, Regulatory Affairs integrates and applies knowledge of US regulatory guidelines and federal regulations governing pharmaceutical drug development to all aspects of Our Clients s drug development programs, polici ...
-
manager regulatory affairs
4 days ago
TK-CHAIN LLC Princeton, United StatesJob Description · Job Description · SUMMARY OF POSITION · Manages team and leads Regulatory Associates and/or Senior Regulatory Associates in regulatory activities associated with planning, authoring, compiling and submitting highest-quality regulatory submissions to the FDA with ...
-
Director Regulatory Affairs
1 week ago
Lynkx Staffing LLC Princeton, United StatesJob Description · Job DescriptionOur Pharmaceutical client is seeking a Director Regulatory Affairs Chemistry Manufacturing & Controls (CMC) to guide global teams through the development and execution of regulatory strategy and the design of CMC components of drug development pro ...
-
Regulatory Affairs Intern
3 weeks ago
Dr. Reddy's Laboratories Inc. Princeton, United States OTHERAt Dr. Reddy's "Good Health Can't Wait" · By joining Dr. Reddy's, you will contribute to making the breakthroughs of tomorrow a reality today From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to help ...
-
Regulatory Affairs Intern
3 weeks ago
Dr. Reddy's Laboratories Inc. Princeton, United States OTHERAt Dr. Reddy's "Good Health Can't Wait" · By joining Dr. Reddy's, you will contribute to making the breakthroughs of tomorrow a reality today From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to he ...
-
Regulatory Affairs Specialist Ii
1 week ago
Katalyst Healthcares & Life Sciences Inc Edison, United States**Responsibilities**: · - This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe, support of international product registrations and related regulatory affairs activities, including execution of pr ...
-
Regulatory Affairs Consultant
1 week ago
Katalyst Healthcares and Life Sciences Cranbury, United StatesResponsibilities: Provides strategic global regulatory guidance to cross-functional project teams responsible for product development. · ctively leads the development and implementation of regulatory strategies for assigned programs and ensures cross-functional alignment. · Coo ...
-
Senior Director Regulatory Affairs
5 days ago
Sun Pharma Princeton, United StatesSenior Director, Regulatory Affairs - GDP · Shionogi Inc. · posted 05/06/2024 · More... · front runner · Senior Director, Regulatory Affairs CMC · Meet · Philadelphia, PA 19117 · posted 05/09/2024 · More... · front runner · Senior Director Regulatory Affairs · Sun Pharma ...
-
Senior Director Regulatory Affairs
2 weeks ago
SUN PHARMA Princeton, United StatesThe Brands and Innovative Medicines Global Regulatory Affairs organization is seeking a Senior Director, Global Regulatory Portfolio Leader. Working with leaders across the organization, this individual will provide leadership for the regulatory strategy of one or more in-line an ...
-
Senior Director Regulatory Affairs
2 weeks ago
Sun Pharma Princeton, United StatesThe Brands and Innovative Medicines Global Regulatory Affairs organization is seeking a Senior Director, Global Regulatory Portfolio Leader. Working with leaders across the organization, this individual will provide leadership for the regulatory strategy of one or more in-line an ...
Specialist - Regulatory Affairs - Plainsboro, United States - Novo Nordisk
Description
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
Provide proactive support and technical assistance to more experienced regulatory personnel. Identify issues and inform appropriate individuals. Ability to work with less supervision than Associate. Take initiative to assist with overflow in other areas as needed.
Relationships
Reports to a Manager, Senior Manager, Associate Director or Director. Works with personnel in other departments including Marketing, CMR, Legal, and counterparts in NNAS Regulatory Affairs. Has a positive approach to work projects and maintains constructive and positive interactions with colleagues.
Essential Functions
Physical Requirements
0-10% overnight travel required.
Qualifications
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 This contact is for accommodation requests only and cannot be used to inquire about the status of applications.