Requisition ID 15234BR
Title Director, Regulatory Policy
Job Category Regulatory Affairs
Job Description PURPOSE:
The Director, Regulatory Policy will act as the single point of contact for US regulatory policy initiatives and activities at Novo Nordisk. This key role will be responsible for assessing, integrating, shaping and maintaining the company’s regulatory policy positions with FDA. The incumbent will build and maintain relationships with key FDA staff in this role and will possess a deep understanding of FDA as well as the driver of the Novo Nordisk business. He/She will 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. Will be a key member of Novo Nordisk US (NNI) Regulatory Affairs Team.
RELATIONSHIPS:
Reports to the Vice President of Regulatory Affairs, NNI. Interacts with key company personnel both within and outside of Novo Nordisk-US. Collaborates with other departments to understand and influence the US regulatory environment, particularly FDA. May act as FDA liaison on critical company issues.
The Director, US Regulatory Policy is responsible for developing Novo Nordisk’s regulatory policy for the US and in conjunction with US Regulatory Affairs staff, providing Novo Nordisk’s position to industry thought leaders and US regulators, particularly FDA.
ESSENTIAL FUNCTIONS:
• 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.
• Proactively monitors emerging scientific trends/strategies, both internally and externally, to shape and influence changes in the US regulatory environment. Under the supervision of the VP, US Regulatory Affairs at NNI, the incumbent will represent Novo Nordisk in assigned areas on pharma industry committees and maintain productive relationships with industry staff and FDA staff to ensure productive Agency interactions.
• Plans and manages interactions with NNI and Novo Nordisk Corporate (NN A/S) regulatory management and liaison staff for submission of product applications and other related interactions with FDA.
• Monitor emerging regulatory policy issues in assigned areas, including issues arising from FDA or other regulatory authorities, Congress, within the pharmaceutical industry or elsewhere, and identifies those issues likely to impact Novo Nordisk’s regulatory strategy or product portfolio. In consultation with VP, US Regulatory Affairs at NNI, coordinates and leads internal teams to address regulatory policy issues.
• Coordinate with appropriate internal staff to develop Novo Nordisk responses to FDA draft regulations, guidelines and policies and plans and manages interactions and communications with FDA on regulatory policy matters.
• Participate in appropriate regulatory project team meetings and rehearsals for FDA meetings to learn about product matters likely to surface which may require involvement/action of Regulatory Policy staff.
• Maintain liaison with outside scientific and professional organizations to represent Novo Nordisk on product and regulatory policy matters under the supervision of the VP, US Regulatory Affairs at NNI.
• Participate in industry and professional meetings to maintain competency on regulatory policy issues.
PHYSICAL REQUIREMENTS:
Some overnight travel
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
An advanced/ Doctorate degree in a life science discipline, health care, public health, health policy, or law
Minimum 10 years pharmaceutical regulatory experience, including a minimum of 8 years FDA/HHS and/ or regulatory policy experience.
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.
Demonstrated record of developing robust and successful regulatory policy positions and strategies.
Documented success in regulatory aspects of US regulatory policy development and ability to influence the FDA environment.
Department CMR - REG AFFAIRS
Position Location US - Washington, DC
City Washington DC
State/Provinces US - DC
Degree Required Master's Degree Required
Percent Travel 20 - 30%
Title Director, Regulatory Policy
Job Category Regulatory Affairs
Job Description PURPOSE:
The Director, Regulatory Policy will act as the single point of contact for US regulatory policy initiatives and activities at Novo Nordisk. This key role will be responsible for assessing, integrating, shaping and maintaining the company’s regulatory policy positions with FDA. The incumbent will build and maintain relationships with key FDA staff in this role and will possess a deep understanding of FDA as well as the driver of the Novo Nordisk business. He/She will 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. Will be a key member of Novo Nordisk US (NNI) Regulatory Affairs Team.
RELATIONSHIPS:
Reports to the Vice President of Regulatory Affairs, NNI. Interacts with key company personnel both within and outside of Novo Nordisk-US. Collaborates with other departments to understand and influence the US regulatory environment, particularly FDA. May act as FDA liaison on critical company issues.
The Director, US Regulatory Policy is responsible for developing Novo Nordisk’s regulatory policy for the US and in conjunction with US Regulatory Affairs staff, providing Novo Nordisk’s position to industry thought leaders and US regulators, particularly FDA.
ESSENTIAL FUNCTIONS:
• 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.
• Proactively monitors emerging scientific trends/strategies, both internally and externally, to shape and influence changes in the US regulatory environment. Under the supervision of the VP, US Regulatory Affairs at NNI, the incumbent will represent Novo Nordisk in assigned areas on pharma industry committees and maintain productive relationships with industry staff and FDA staff to ensure productive Agency interactions.
• Plans and manages interactions with NNI and Novo Nordisk Corporate (NN A/S) regulatory management and liaison staff for submission of product applications and other related interactions with FDA.
• Monitor emerging regulatory policy issues in assigned areas, including issues arising from FDA or other regulatory authorities, Congress, within the pharmaceutical industry or elsewhere, and identifies those issues likely to impact Novo Nordisk’s regulatory strategy or product portfolio. In consultation with VP, US Regulatory Affairs at NNI, coordinates and leads internal teams to address regulatory policy issues.
• Coordinate with appropriate internal staff to develop Novo Nordisk responses to FDA draft regulations, guidelines and policies and plans and manages interactions and communications with FDA on regulatory policy matters.
• Participate in appropriate regulatory project team meetings and rehearsals for FDA meetings to learn about product matters likely to surface which may require involvement/action of Regulatory Policy staff.
• Maintain liaison with outside scientific and professional organizations to represent Novo Nordisk on product and regulatory policy matters under the supervision of the VP, US Regulatory Affairs at NNI.
• Participate in industry and professional meetings to maintain competency on regulatory policy issues.
PHYSICAL REQUIREMENTS:
Some overnight travel
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
An advanced/ Doctorate degree in a life science discipline, health care, public health, health policy, or law
Minimum 10 years pharmaceutical regulatory experience, including a minimum of 8 years FDA/HHS and/ or regulatory policy experience.
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.
Demonstrated record of developing robust and successful regulatory policy positions and strategies.
Documented success in regulatory aspects of US regulatory policy development and ability to influence the FDA environment.
Department CMR - REG AFFAIRS
Position Location US - Washington, DC
City Washington DC
State/Provinces US - DC
Degree Required Master's Degree Required
Percent Travel 20 - 30%