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
We are seeking a Regulatory Professional who will be responsible for providing regulatory support to the Global Regulatory Lead (GRL) for global regulatory deliverables (i.e. US, FDA, JPN, and other regions) in all stages of development across multiple programs.
Relationships
Reports to a Director, Regulatory Affairs.
Essential Functions
Contribute to the preparation, review, approval, and dispatch of global submissions to regulatory applications (pre-submission activities, orphan drug applications, IND/INDs/CTAs/NDAs/MAAs etc.)Support the planning and conduct of regulatory interactions with health authorities; provide input to the preparation of meeting requests, meeting packages, meeting rehearsals, and taking minutes of formal meetings, as neededMaintain and archive regulatory documentation in Novo Nordisk systems including submissions to and correspondence with governing competent authoritiesCreate and maintain regulatory trackers and timelines, management updates, schedule team meetings, prepare agendas and minutes for regulatory team and submission team meetings; and follow-up on action items with cross-functional team membersContribute to the development of risk assessments pertaining to the quality, safety and efficacy documentation/data of investigational medicinal products related applicationsPerform regulatory intelligence research including precedents on prior approvals, clinical endpoints, competitive trial design, and comparison of competitor labels; keep up-to-date on regulatory legislation and guidelinesMaintain and support the development of the global regulatory strategy document with the GRLRepresent regulatory on clinical trial study team meetings; coordinate with the GRL to provide regulatory feedback to the cross-functional teamPlan for and assist with regulatory inspections, as neededReview submission documentation, including clinical and technical documentation for regulatory compliancePrepare and deliver effective presentations for internal audiences
Physical Requirements
0-10% overnight travel required.
Qualifications
Bachelor’s degree required. Master’s or an advanced degree preferredA minimum of 3 years of progressively responsible related experience; including hands on related pharmaceutical or medical device/pharmaceutical combination product experiencePrevious experience working with electronic document management systems required (e.g. Veeva)Advanced expertise using Microsoft Office Suite (Outlook, Word, PowerPoint, Excel, SharePoint), Adobe Acrobat Professional, and eCTD content templates)Strong organizational and demonstrated problem-solving capabilitiesUnderstanding of the drug development process and knowledge of global regulatory requirements for drugs and biologicsOutstanding written and oral communication skills, with an adept ability to deal effectively with a variety of personnel including medical, scientific and manufacturing staffAbility to thrive in a busy environment and maintain a positive attitude under pressureProactive individual who displays abilities for increased independence in Regulatory Affairs with moderate oversight
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.
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