TITLE: Lead Regulatory Scientist - Princeton, NJ

Job Description
Assist senior Regulatory Affairs personnel in assuring compliance. Submit all types of applications to FDA. Provide significant input into development of regulatory strategy documents. Responsible for development of regulatory submission strategies.

RELATIONSHIPS:
Reports to the designated Director or Senior Director, Therapeutic Area. Works with other personnel in the Medical Department and counterparts in NNAS Regulatory Affairs. External relationships include interaction with FDA personnel regarding project issues. Promotes and develops initiatives to continually improve working relationships within and across departments in relation to department and company goals and objectives. Acts as an advisor to subordinates. May supervise or manage junior or more experienced personnel. May lead FDA meetings.

ESSENTIAL FUNCTIONS:

1)SUBMISSIONS:
·Submit all types of applications to FDA.
·Provide significant input into development of comprehensive regulatory strategy documents.
·Facilitate and organize the compilation of applications (IND, NDA, Biologics, Devices) to government agencies in support of research and marketed products. Maintain up-to-date knowledge of the data, information, and formats required for inclusion in these applications.
·Act as liaison with Novo Nordisk and NNAS departments for preparation of documentation necessary for submission of applications.
·Review data from contributing departments (including NNAS) and provide comments to assure accurate and complete documents for inclusion in these applications.
·Supervise and coordinate the planning of FDA submissions for assigned products/projects to ensure most efficient use of resources.
·Approve specified regulatory submissions.

2)FDA COMPLIANCE:
·Provide training to the Sales Reps as needed. Provide information and training for NNAS in areas of IND, NDA, and 501(k) processes.
·Disseminate information on proposed and new FDA regulations and guidelines for assigned products/projects.
·Supervise the review and sign-off on all labeling for marketed products prior to use for assigned products/projects.

3)FDA INTERACTIONS:
·May act as FDA liaison for most project issues.
·Lead FDA meetings.
·Lead label negotiations.
·Participate in and/or coordinate all negotiations and interactions with FDA personnel on projects as assigned.

4)PRODUCT DEVELOPMENT AND SUPPORT:
·Manage moderately complex to complex projects.
·May act as GRT member.
·Coordinate and supervise the development of regulatory strategies for new or modified pharmaceutical products and for 510(k) devices under development or license for assigned projects.
·Supervise all regulatory activities relating to regulatory compliance for assigned marketed and investigational products.
·Supervise and advise staff members.

DEVELOPMENT OF PEOPLE:
·Manage assigned junior to more experienced personnel as direct report.
·Ensure that reporting personnel have 3P forms, as well as own 3P form, which have annual goals and measurements, are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities. Understand their level of accountability for results and the measurement process.
·Ensure that the IDP development forms are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.
·Review subordinates 3P and IDP's.
·Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way of Management.
·Contribute to development of Therapeutic Area Associates and Managers.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
·Bachelors/Life Science degree required. Advanced degree preferred.
·Minimum 6 years regulatory experience required; 10 years total industry/FDA experience.
·Regulatory project management experience required; supervisory management experience preferred.
·Experience and knowledge of the current requirements of FDA.
·Excellent communication and leadership skills are essential. Ability to establish sound working relationships with different types of people with differing levels of skill and background is essential.


Additional Information
Position change form - was aligned to SR Dir (SCTR) - changed to a Lead Regulatory Scientist