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Manager - Regulatory Affairs - Therapeutic Area

Employer
Novo Nordisk
Location
Lexington, MA
Start date
Apr 2, 2024

View more

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

Job Details

About the Department                                                                                                                                             

Our East Coast Global Development Hub brings together the best minds in life science innovation with facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple innovative modalities and therapeutic areas. Our East Coast Global Development Hub merges biotech speed and agility with large pharmaceutical company quality, resources, and stability, uniting the best of both worlds to develop new medicines for patients. We recognize that improving human health starts here and that patients rely on us. 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 global regulations, including compilation and submission of any required documents to regulatory agencies.

 

Relationships

Report to a Director of Regulatory Affairs. Develop and maintain positive rapport and working relationships with other personnel in Regulatory Affairs and other local and headquarter departments to accomplish company goals. External relationships may include interactions with personnel from FDA or other regulatory agencies regarding assigned projects and roles.

 

Essential Functions

  • Compile, submit and maintain applications (IND, CTAs, NDAs etc.) to regulatory agencies in support of investigational and marketed products, including compiling and submitting responses to agency queries
  • Create and maintain product/project database to record history of questions asked / responses received during agency interactions
  • Liaise with cross-functional departments for preparation of documentation necessary for submission of applications
  • Maintain up-to-date knowledge of laws, regulations and guidance documents as they relate to pharmaceuticals
  • Maintain up-to-date knowledge of the data, information, and formats required for inclusion in regulatory applications
  • Manages development projects or portions of projects
  • May act as FDA liaison for routine contacts and handle finalization of routine correspondence
  • Serve as a key member of the matrix regulatory team including generation of meeting agenda and minutes
  • Provide oversight of annual reports
  • Participate in project team meetings as assigned
  • Review data from contributing departments and provide comments to assure accurate and complete documents for inclusion in regulatory applications
  • Contribute to the generation and review of regulatory strategy documents
  • Research and analyze the evolving competitive and regulatory landscapes to maintain current knowledge
  • Work with Global Regulatory Lead and team to draft meeting requests and supporting briefing packages for agency meetings
  • Write Regulatory documents translating team strategy into regulatory overview documents such as cover letters, pre-meeting package, and other regulatory positioning documents to assist Global Regulatory Leads

 

Physical Requirements

0-10% overnight travel required.

 

Qualifications

  • A Bachelor’s degree required with a minimum of 4 years of regulatory affairs experience; or a Master’s degree with a minimum of 3 years of regulatory affairs experience; or a Doctorate degree with a minimum of 1 year of regulatory affairs experience within the pharmaceutical/biotech industry. Life Science and advanced degree preferred.
  • Advanced knowledge of pertinent regulations and guidance documents
  • 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
  • Strong organizational and demonstrated problem-solving capabilities
  • Ability to thrive in a busy environment and maintain a positive attitude under pressure
  • Knowledge of rare disease and/or expedited regulatory pathways beneficial
  • Works independently with minimal supervision
  • Previous hands on experience with compilation and filing of INDs/NDAs/Amendments/Supplements desired

 

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
US

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