Manager - Regulatory Affairs - Therapeutic Area
Novo Nordisk
- Lexington, MA
- Permanent
- Full-time
Accept ClosePress Tab to Move to Skip to Content LinkSearch by KeywordSearch by LocationLoading...Category×Select how often (in days) to receive an alert:×Select how often (in days) to receive an alert:Manager - Regulatory Affairs - Therapeutic AreaFacility: Reg Affairs & Safety PharmacovigilanceLocation:Lexington, MA, USAbout the DepartmentOur 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 PositionManage 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.RelationshipsReport 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
- 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