Oversee all assigned projects/products/processes. Assist the Executive Director in assuring Novo Nordisk compliance with internal SOPs and Federal and State regulations, including compilation and submission of any required documents to regulatory agencies. Act as liaison with FDA for assigned projects. Supervises designated personnel.
Report to the Executive Director Regulatory Affairs. Interact with key company personnel both within and outside of Novo Nordisk-US as related to assigned projects. Develop and maintain positive rapport and working relationships with other personnel in Regulatory Affairs, CMR, and other local and headquarter departments in support of initiatives and to accomplish company goals. FDA liaison for designated projects or as requested by supervisor. Supervises junior Regulatory Affairs staff.
* Assist the Director in development and implementation of strategy to maintain efficient and compliant PRB process.
* Assure company compliance with FDA and FTC requirements and strategy.
* Assure full regulatory compliance of all promotions with approved labeling.
* Build a strong relationship with internal customers; including Marketing, International Marketing, Marketing Operations, Legal and Medical.
* Build a strong relationship with the FDA in promotional area.
* Ensure timely and accurate submission of promotional materials to FDA in Form 2253.
* Lead regulatory promotional reviewer for new product launches.
* Maintain up-to-date knowledge of laws, regulations and policies enforced by the Federal and State governments as they relate to advertising and promotion of pharmaceuticals and devices. Advise appropriate departments within the company (NNI and NNAS) of these requirements. Assist the Director in establishing procedures to assure compliance with these requirements.
* Oversee preparation and submission of draft introductory materials to FDA for comment.
* Provide regulatory review of draft promotional materials (pre-PRB).
* Provide training in FDA regulations for advertising and promotion to employees and agents of Novo Nordisk.
* Regulatory PRB reviewer.
* Review draft and final advertising/promotional materials for marketed products, as assigned.
* Review of draft promotional campaigns prepared by International Marketing for compliance with FDA regulations.
* Support development of launch materials/new claims by collaborating with Marketing, Medical and Legal. Prepare FDA submissions of draft introductory promotional materials.
Some overnight travel
DEVELOPMENT OF PEOPLE:
* Contribute to development of Associates and Managers.
* Ensure that reporting personnel have timely performance evaluation forms with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process.
* Ensure that the IDP forms include completed Learning and Aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.
* For global projects, advise members of the global regulatory team and provide input to goal setting and performance appraisal for team members in head quarters within assigned projects.
* Manage assigned junior to more experienced personnel and their simple projects or portions of projects as direct report(s).
* Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way of Management.
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
* A Bachelors required/Advance degree preferred; Life Science degree preferred; expertise in project area/s preferred.
* Ability to establish sound working relationships.
* Ability to work independently.
* Detail & deadline oriented; well organized.
* Excellent verbal and written communication skills essential.
* Experience and knowledge of the relevant current requirements of FDA required.
* For global projects, prior interaction or exposure with other key regulatory authorities e.g. EMEA, EU national authorities, PMDA
* Good interpersonal skills; ability to interact with staff on all levels.
* Minimum 6 years regulatory experience. 8 years total pharmaceutical/related industry experience.
* Project management experience required, supervisory experience strongly preferred.
Department CMR - REG AFFAIRS (2a)
Position Location US - Princeton, NJ
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 0 - 10%
Nearest Major Market: New Jersey
Job Segments: Medical, Regulatory Affairs, Law, Claims, Compliance, Healthcare, Legal, Insurance