Director - Regulatory Affairs - Therapeutic Area -

Company: Novo Nordisk
Location: Plainsboro
Posted on: May 14, 2022

Job Description:

About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient-centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We---re changing lives for a living. Are you ready to make a difference? The Position Responsible for portfolio within Therapeutic Area. Provide significant input into comprehensive regulatory strategy documents. Develop company-wide regulatory and quality systems. Assure compliance. Relationships External relationships include interaction with FDA personnel regarding product/project issues. Promotes and develops initiatives to continually improve working relationships within and across departments in relation to department and company goals and objectives. Leads project teams. Acts as an advisor to staff or team members to meet schedules or resolve problems in dealing with the FDA. Reports to Executive Director/Senior Director Regulatory Affairs. Provides input into development of regulatory strategies. Works with other personnel in the Novo Nordisk-US Clinical Development, Medical Affairs, Marketing areas and counterparts in NNAS, including global regulatory team and global project team. Essential Functions FDA Compliance Advise senior management of FDA requirements and standards, and assure company compliance Build a strong relationship with the FDA Champion company projects and products; present programs, discuss and resolve issues, and support obtaining prompt approvals Make recommendations on potential strategy and activities Serve as FDA liaison on critical company issues Support of new or modified pharmaceutical products and 510(k) devices or combinations FDA Interactions Direct negotiations and facilitate interactions with regulatory agencies and corporate groups regarding regulatory responsibilities FDA liaison for all project issues FDA liaison on critical company issues Lead FDA meetings Lead major label negotiations Product Development and Support Act as GRT member Position Novo Nordisk-US favourably to facilitate product development Provide for training and dissemination of information as necessary for Regulatory Affairs or other departments Work with HQ global regulatory teams and global project teams to ensure coordinated, compliant implementation of global development programs Submissions Approve specified regulatory submissions Perform or supervise regulatory review of all documents for submissions; e.g., clinical protocols and study reports; preclinical reports; chemistry, manufacturing and control reports, investigator brochures, application summary documents Plan regulatory submission strategies to best utilize resources Provide training to the regulatory staff, other Novo Nordisk groups (including sales and marketing) as needed. Provide information for NNAS in areas of US regulatory processes Implement new FDA regulations and guidelines for assigned products/projects Responsible for development of regulatory submission strategies Physical Requirements 0-10% overnight travel required. Qualifications A Bachelors required/Advance degree preferred; Life Science degree preferred Minimum of 10 years total pharmaceutical/FDA/regulatory related industry experience required Regulatory project management experience required inclusive of regulatory filings and approvals (IND, NDA, BLA, 510K, etc.) Proven ability to develop robust regulatory strategies required Excellent verbal and written communication required Experience and knowledge of the current requirements of FDA The ability to establish sound working relationships 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. Novo Nordisk requires all new hires to be fully vaccinated against COVID-19 prior to the first date of employment. As required by applicable law, Novo Nordisk will consider requests for reasonable accommodation. 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.

Keywords: Novo Nordisk, Trenton , Director - Regulatory Affairs - Therapeutic Area -, Executive , Plainsboro, New Jersey