About the Department
The Lexington Site is home to a growing Development organization, part of Novo Nordisk following its acquisition of Dicerna Pharmaceuticals, Inc. in December 2021. The Lexington Development team is responsible for leading the clinical advancement of Dicerna’s research pipeline of GalXC™ and GalXC-Plus™ RNAi investigational therapies and select candidates from the broader Novo Nordisk portfolio, targeting both rare and prevalent diseases. The Lexington Development team’s rich heritage of collaboration, calculated risk-taking and agility complemented by the scale and resources of the global Development organization, define a unique clinical development team that maintains its agility to efficiently advance clinical candidates through development. Located in one of the most vibrant biotechnology innovation hubs in the world, and part of the growing biotech ecosystem in Lexington, Massachusetts, the Lexington Site will offer you the opportunity to collaborate with extraordinary talent and to continuously develop, while working toward our collective mission to improve patient lives. Together, we are driving change. Are you ready to make a difference?
We are seeking a Senior Specialist - Regulatory Affairs 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.
Reports to a Director, Regulatory Affairs.
- 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 needed
- Maintain and archive regulatory documentation in Novo Nordisk systems including submissions to and correspondence with governing competent authorities
- Create 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 members
- Contribute to the development of risk assessments pertaining to the quality, safety and efficacy documentation/data of investigational medicinal products related applications
- Perform 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 guidelines
- Maintain and support the development of the global regulatory strategy document with the GRL
- Represent regulatory on clinical trial study team meetings; coordinate with the GRL to provide regulatory feedback to the cross-functional team
- Plan for and assist with regulatory inspections, as needed
- Review submission documentation, including clinical and technical documentation for regulatory compliance
- Prepare and deliver effective presentations for internal audiences
0-10% overnight travel required.
- Bachelor’s degree required. Master’s or an advanced degree preferred
- A minimum of 2+ years of progressively responsible related experience; including hands on related pharmaceutical or medical device/pharmaceutical combination product experience
- Previous 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 capabilities
- Understanding of the drug development process and knowledge of global regulatory requirements for drugs and biologics
- Outstanding written and oral communication skills, with an adept ability to deal effectively with a variety of personnel including medical, scientific and manufacturing staff
- Ability to thrive in a busy environment and maintain a positive attitude under pressure
- Proactive 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.