Regulatory Principal Specialist / Global Regulatory Lead

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Join Regulatory Affairs (RA) and become part of an exciting environment where engaged people are committed gaining approval of Novo Nordisk’s medicines by regulatory authorities across the globe. Our people have a unique combination of scientific insight, patient focus, and the ability to navigate many agendas and stakeholders. That makes Regulatory Affairs a truly interesting and challenging place to work.

About the department

RA Oral Peptide & Cardiovascular Disease (CVD) Projects are responsible for development projects within the innovative new delivery technology that brings peptides in tablets available to patients or development projects for cardiovascular diseases. We are 13 dedicated and highly engaged employees working in the department.

We work as an integrated part of the global research and development cross-functional project teams. We are responsible for the regulatory strategy and provide regulatory expertise and tactics to the product development plan. We drive label development, Health Authority interactions and clinical trial applications. We have a strong collaboration with our affiliates.

We are currently looking for a Regulatory Specialist with a scientific background combined with extensive regulatory and drug development experience to take on the role as Global Regulatory Lead (GRL) for CVD projects in early or late phase of development and be responsible for the global regulatory strategy.

The job

As Regulatory Specialist/GRL you will be responsible for the project plan and project execution, provide regulatory input for the project strategy, interact with internal and external stakeholders (e.g. Health Authorities) and represent Regulatory Affairs in global project teams. Here, you ensure regulatory deliverables according to agreed timelines, cost and quality. You will assume the role of the challenger who makes an impact, seeks solutions and drive innovations.

Furthermore, you will lead global regulatory teams being responsible for regulatory activities in CVD projects. As a Regulatory Specialist/GRL, you will be overall responsible for submission and approval of clinical trial applications, for driving and coordinating preparation of meeting packages to Health Authorities, conduct Health Authority interactions and for regulatory submissions and approvals. You will interact with medical specialists, researchers and regulators. All in all, you will have a large responsibility and you will have a lot of influence and impact on the way we reach our goals.

You will report to the Senior Director of RA Oral Peptide & CVD Projects and take active part in department related activities, including improvement projects across RA.

Qualifications

We expect you to have a university degree in life science preferably complemented by a PhD and have 6-8 years of regulatory and/or drug development experience. From your career you have solid experience of handling regulatory documentation for pharmaceutical development within the quality, non-clinical and clinical area. You have experience interacting directly with regulatory authorities on an international scale. You have proven strong negotiation skills and a sound business understanding. You also know how to set direction, lead and motivate your team to work for joint objectives. At the same time, you are the team player who assists your colleagues.

As a person you are well-organised and have solid problem-solving capabilities, just as you show a winning attitude and never lose your strategic focus. You can keep your spirits high even when under pressure. You are a skilled communicator who can work at any organisational level. Finally, you are comfortable using your fluent written and spoken English on a daily basis.

Skriv i din ansøgning, at du fandt jobbet på ofir.dk


Regulatory Principal Specialist / Global Regulatory Lead

Join Regulatory Affairs (RA) and become part of an exciting environment where engaged people are committed gaining approval of Novo Nordisk’s medicines by regulatory authorities across the globe. Our people have a unique combination of scientific insight, patient focus, and the ability to navigate many agendas and stakeholders. That makes Regulatory Affairs a truly interesting and challenging place to work.

About the department

RA Oral Peptide & Cardiovascular Disease (CVD) Projects are responsible for development projects within the innovative new delivery technology that brings peptides in tablets available to patients or development projects for cardiovascular diseases. We are 13 dedicated and highly engaged employees working in the department.

We work as an integrated part of the global research and development cross-functional project teams. We are responsible for the regulatory strategy and provide regulatory expertise and tactics to the product development plan. We drive label development, Health Authority interactions and clinical trial applications. We have a strong collaboration with our affiliates.

We are currently looking for a Regulatory Specialist with a scientific background combined with extensive regulatory and drug development experience to take on the role as Global Regulatory Lead (GRL) for CVD projects in early or late phase of development and be responsible for the global regulatory strategy.

The job

As Regulatory Specialist/GRL you will be responsible for the project plan and project execution, provide regulatory input for the project strategy, interact with internal and external stakeholders (e.g. Health Authorities) and represent Regulatory Affairs in global project teams. Here, you ensure regulatory deliverables according to agreed timelines, cost and quality. You will assume the role of the challenger who makes an impact, seeks solutions and drive innovations.

Furthermore, you will lead global regulatory teams being responsible for regulatory activities in CVD projects. As a Regulatory Specialist/GRL, you will be overall responsible for submission and approval of clinical trial applications, for driving and coordinating preparation of meeting packages to Health Authorities, conduct Health Authority interactions and for regulatory submissions and approvals. You will interact with medical specialists, researchers and regulators. All in all, you will have a large responsibility and you will have a lot of influence and impact on the way we reach our goals.

You will report to the Senior Director of RA Oral Peptide & CVD Projects and take active part in department related activities, including improvement projects across RA.

Qualifications

We expect you to have a university degree in life science preferably complemented by a PhD and have 6-8 years of regulatory and/or drug development experience. From your career you have solid experience of handling regulatory documentation for pharmaceutical development within the quality, non-clinical and clinical area. You have experience interacting directly with regulatory authorities on an international scale. You have proven strong negotiation skills and a sound business understanding. You also know how to set direction, lead and motivate your team to work for joint objectives. At the same time, you are the team player who assists your colleagues.

As a person you are well-organised and have solid problem-solving capabilities, just as you show a winning attitude and never lose your strategic focus. You can keep your spirits high even when under pressure. You are a skilled communicator who can work at any organisational level. Finally, you are comfortable using your fluent written and spoken English on a daily basis.

Skriv i din ansøgning, at du fandt jobbet på ofir.dk


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