Manager - Regulatory Affairs

Location

Lexington, MA | United States

Job description

About the Department

Our Boston Research & Development hub, anchored in the greater Boston area, brings together the best minds in life science innovation. The teams located in facilities in Lexington, Watertown and Cambridge reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, 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. Our greater Boston R&D 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.

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; Life Science and advanced degree preferred
• A minimum of 4 years of progressively responsible related experience; including hands on related pharmaceutical or medical device/pharmaceutical combination product experience and actual regulatory experience
• 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.

Job tags

Salary