Senior Manager-Associate Director, Regulatory Affairs Job
Date: May 15, 2012
Location: Princeton, NJ, US
Requisition ID 5656BR
Title Senior Manager/Associate Director, Regulatory Affairs
Job Category Regulatory Affairs
Job Description PURPOSE:
Oversee all assigned projects/products/processes. Assist the Director/Sr. Director/AVP 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.
RELATIONSHIPS:
Report to the Director/Sr. 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.
ESSENTIAL FUNCTIONS:
THERAPEUTIC AREA:
* Act as liaison with NNI and NNAS departments for preparation of documentation necessary for submission of applications.
* Approve specified regulatory submissions.
* Assist senior Regulatory Affairs personnel in assuring compliance.
* 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.
* 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.
* FDA liaison on key matters.
* Identify the need for and provide input into development of systems for assigned projects for the efficient operation of the department.
* Lead FDA meetings.
* Lead major label negotiations.
* Major labeling negotiation.
* Manage complex projects.
* May act as FDA liaison for all project issues.
* May act as GRT member.
* Participate in and/or coordinate all negotiations and interacts with FDA personnel as assigned.
* 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.
* Provide input into development of regulatory and quality systems.
* Provide input into development of SOPs for the efficient operation of the department and inter-department activities.
* Provide training to the regulatory staff and Sales Reps as needed.
* Responsible for development of regulatory submission strategies.
* Review data from contributing departments (including NNAS) and provide comments to assure accurate and complete documents for inclusion in these applications.
* Submit all types of applications to FDA.
* Supervise and advise staff members.
* Supervise and coordinate all regulatory activities relating to regulatory compliance for assigned marketed and investigational products.
* Supervise and coordinate the planning of FDA submissions for assigned products/projects to ensure most efficient use of resources.
* Supervise the review and sign-off on all labeling for marketed products prior to use for assigned products/projects.
PHYSICAL REQUIREMENTS:
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 - PROMOTIONAL REVIEW (2)
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 10 - 20%
Title Senior Manager/Associate Director, Regulatory Affairs
Job Category Regulatory Affairs
Job Description PURPOSE:
Oversee all assigned projects/products/processes. Assist the Director/Sr. Director/AVP 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.
RELATIONSHIPS:
Report to the Director/Sr. 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.
ESSENTIAL FUNCTIONS:
THERAPEUTIC AREA:
* Act as liaison with NNI and NNAS departments for preparation of documentation necessary for submission of applications.
* Approve specified regulatory submissions.
* Assist senior Regulatory Affairs personnel in assuring compliance.
* 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.
* 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.
* FDA liaison on key matters.
* Identify the need for and provide input into development of systems for assigned projects for the efficient operation of the department.
* Lead FDA meetings.
* Lead major label negotiations.
* Major labeling negotiation.
* Manage complex projects.
* May act as FDA liaison for all project issues.
* May act as GRT member.
* Participate in and/or coordinate all negotiations and interacts with FDA personnel as assigned.
* 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.
* Provide input into development of regulatory and quality systems.
* Provide input into development of SOPs for the efficient operation of the department and inter-department activities.
* Provide training to the regulatory staff and Sales Reps as needed.
* Responsible for development of regulatory submission strategies.
* Review data from contributing departments (including NNAS) and provide comments to assure accurate and complete documents for inclusion in these applications.
* Submit all types of applications to FDA.
* Supervise and advise staff members.
* Supervise and coordinate all regulatory activities relating to regulatory compliance for assigned marketed and investigational products.
* Supervise and coordinate the planning of FDA submissions for assigned products/projects to ensure most efficient use of resources.
* Supervise the review and sign-off on all labeling for marketed products prior to use for assigned products/projects.
PHYSICAL REQUIREMENTS:
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 - PROMOTIONAL REVIEW (2)
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 10 - 20%
Nearest Major Market: New Jersey
Job Segments: Compliance, Law, Legal, Management, Manager, Outside Sales, Pharmaceutical, Pharmaceutical Sales, Project Manager, Quality, Regulatory Affairs, Research, Sales, Science, Technology