Requisition ID 15433BR
Title Executive Director – Regulatory Affairs, Biopharm
Job Category Regulatory Affairs
Job Description Develop and cultivate group vision and structure to achieve company regulatory objectives. Direct successful regulatory strategies to meet company goals. Maintain compliance of all internal and external policies and regulations. Ensure efficient processes to meet internal and external timelines. Design and promote systems to continually improve business productivity within and across departments in relation to department and company goals and objectives. Display technical and strategic regulatory leadership of assigned therapeutic area(s) Develop and advocate the use of innovative regulatory strategies in line with the needs of the business with an understanding of the requirement to balance opportunity and risk. Manages regulatory staff who perform advertising and promotional review activities for Novo Nordisk approved products. Key member of NNI RA Leadership Team.
RELATIONSHIPS:
Reports to the Vice President of Regulatory Affairs. Interacts with key company personnel both within and outside of Novo Nordisk-US. Collaborates with other departments to ensure adherence to U.S. regulations and company SOPs. Directly supervises senior Regulatory Affairs staff and acts as an advisor to all staff to achieve department and corporate goals. FDA liaison on critical company issues.
ESSENTIAL FUNCTIONS:
FDA COMPLIANCE AND INTERACTIONS:
Advise senior management of FDA requirements and standards related to drug development, life-cycle management and regulatory compliance activities.
Build a strong relationship with the FDA.
Direct negotiations and management of strategic FDA interactions.
Ensure that systems are in place for the review of and actions on any FDA regulatory submission.
Facilitate communications with other regulatory agencies as appropriate based on business needs.
FDA liaison on critical company issues.
Perform or supervise regulatory review of all documents for submission.
Provide efficient processes to meet on time submission of all regulatory documentation including new applications, supplemental NDAs/BLAs, annual reports, and other data submissions.
INTERNAL REGULATORY COMPLIANCE:
Direct negotiations and facilitate interactions with corporate groups regarding regulatory responsibilities
Ensure implementation of new FDA regulations and guidelines.
Ensure systems in place to provide training to the regulatory staff, other Novo Nordisk groups (including sales and marketing) as needed.
Establish processes to ensure compliance with internal and external timelines, such as for responses to FDA.
Maintain up-to-date knowledge of the regulations and guidelines issued by the FDA along with other industry periodicals impacting regulatory issues.
Provide information for Novo Nordisk A/S on the US regulatory environment, guidances, and policies. Develop innovative strategies to optimally position NN projects with FDA.
PRODUCT DEVELOPMENT SUPPORT:
Champion company projects and products; present programs, discuss and resolve issues, and support obtaining prompt approvals.
Develop systems and strategies to achieve company goals and ensure regulatory and product compliance in support of new or modified pharmaceutical products and 510(k) devices or combinations thereof under development or approved.
Ensure robust submission strategies developed by staff. Possesses a high level of business acumen.
Ensure timelines are met to achieve company goals.
Manages regulatory staff who perform advertising and promotional review activities for Novo Nordisk Inc. . approved products
Position Novo Nordisk-US favorably to facilitate product development.
Work with HQ global teams to ensure coordinated, compliant implementation of global development programs with a deep understanding of the US regulatory perspective.
PHYSICAL REQUIREMENTS:
Some overnight travel
DEVELOPMENT OF PEOPLE:
Act as principle coach and mentor for direct reports. Ensure that reporting personnel have 3P forms, 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. Explain 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.
Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way of Management.
Review subordinates 3P and IDP’s.
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
A Doctorate or advanced degree preferred; Life Science degrees preferred.
Documented success in regulatory aspects of US advertising and promotional review activities as well as US FDA standards.
Excellent communication and leadership skills are essential. Ability to establish sound working relationships., within NNI, at NN A/S and with FDA staff as appropriate.
Experience and knowledge of the current FDA requirements and industry standards.
Minimum 10 years regulatory experience; 15 years total industry/FDA experience. Significant product development experience and track record of successful registration of new medicines/devices in the US.
Proven ability to develop robust and successful regulatory strategies.
Some international experience, preferably dealing with European HQ or affiliates, ideally required.
Substantial people management experience required.
Department CMR - REG AFFAIRS (1)
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Doctorate Degree Required
Percent Travel 10 - 20%
Title Executive Director – Regulatory Affairs, Biopharm
Job Category Regulatory Affairs
Job Description Develop and cultivate group vision and structure to achieve company regulatory objectives. Direct successful regulatory strategies to meet company goals. Maintain compliance of all internal and external policies and regulations. Ensure efficient processes to meet internal and external timelines. Design and promote systems to continually improve business productivity within and across departments in relation to department and company goals and objectives. Display technical and strategic regulatory leadership of assigned therapeutic area(s) Develop and advocate the use of innovative regulatory strategies in line with the needs of the business with an understanding of the requirement to balance opportunity and risk. Manages regulatory staff who perform advertising and promotional review activities for Novo Nordisk approved products. Key member of NNI RA Leadership Team.
RELATIONSHIPS:
Reports to the Vice President of Regulatory Affairs. Interacts with key company personnel both within and outside of Novo Nordisk-US. Collaborates with other departments to ensure adherence to U.S. regulations and company SOPs. Directly supervises senior Regulatory Affairs staff and acts as an advisor to all staff to achieve department and corporate goals. FDA liaison on critical company issues.
ESSENTIAL FUNCTIONS:
FDA COMPLIANCE AND INTERACTIONS:
Advise senior management of FDA requirements and standards related to drug development, life-cycle management and regulatory compliance activities.
Build a strong relationship with the FDA.
Direct negotiations and management of strategic FDA interactions.
Ensure that systems are in place for the review of and actions on any FDA regulatory submission.
Facilitate communications with other regulatory agencies as appropriate based on business needs.
FDA liaison on critical company issues.
Perform or supervise regulatory review of all documents for submission.
Provide efficient processes to meet on time submission of all regulatory documentation including new applications, supplemental NDAs/BLAs, annual reports, and other data submissions.
INTERNAL REGULATORY COMPLIANCE:
Direct negotiations and facilitate interactions with corporate groups regarding regulatory responsibilities
Ensure implementation of new FDA regulations and guidelines.
Ensure systems in place to provide training to the regulatory staff, other Novo Nordisk groups (including sales and marketing) as needed.
Establish processes to ensure compliance with internal and external timelines, such as for responses to FDA.
Maintain up-to-date knowledge of the regulations and guidelines issued by the FDA along with other industry periodicals impacting regulatory issues.
Provide information for Novo Nordisk A/S on the US regulatory environment, guidances, and policies. Develop innovative strategies to optimally position NN projects with FDA.
PRODUCT DEVELOPMENT SUPPORT:
Champion company projects and products; present programs, discuss and resolve issues, and support obtaining prompt approvals.
Develop systems and strategies to achieve company goals and ensure regulatory and product compliance in support of new or modified pharmaceutical products and 510(k) devices or combinations thereof under development or approved.
Ensure robust submission strategies developed by staff. Possesses a high level of business acumen.
Ensure timelines are met to achieve company goals.
Manages regulatory staff who perform advertising and promotional review activities for Novo Nordisk Inc. . approved products
Position Novo Nordisk-US favorably to facilitate product development.
Work with HQ global teams to ensure coordinated, compliant implementation of global development programs with a deep understanding of the US regulatory perspective.
PHYSICAL REQUIREMENTS:
Some overnight travel
DEVELOPMENT OF PEOPLE:
Act as principle coach and mentor for direct reports. Ensure that reporting personnel have 3P forms, 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. Explain 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.
Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way of Management.
Review subordinates 3P and IDP’s.
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
A Doctorate or advanced degree preferred; Life Science degrees preferred.
Documented success in regulatory aspects of US advertising and promotional review activities as well as US FDA standards.
Excellent communication and leadership skills are essential. Ability to establish sound working relationships., within NNI, at NN A/S and with FDA staff as appropriate.
Experience and knowledge of the current FDA requirements and industry standards.
Minimum 10 years regulatory experience; 15 years total industry/FDA experience. Significant product development experience and track record of successful registration of new medicines/devices in the US.
Proven ability to develop robust and successful regulatory strategies.
Some international experience, preferably dealing with European HQ or affiliates, ideally required.
Substantial people management experience required.
Department CMR - REG AFFAIRS (1)
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Doctorate Degree Required
Percent Travel 10 - 20%