Global Regulatory Lead for Device Project
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Søborg
Are you experienced in developing therapeutic products or devices and skilled at creating regulatory strategies together with external collaborators? Do you have a good understanding of the therapeutic value chain? If you want to make a difference and be part of an innovative company using technology for new devices for the management of Diabetes and Obesity, apply now!
The position
As a Global Regulatory Lead, you will be overall accountable for developing and executing regulatory strategies with challenging and often overlapping timelines. You will lead regulatory matrix teams which includes leads from different areas within RA. You will collaborate with external collaborators that have a common interest in the project. The role offers breadth of responsibility, complexity, and organizational visibility, and you will have a lot of influence and impact on the project direction and decisions.
Your main responsibilities will be focused on:
• Representing Regulatory Affairs in Global Project Team
• Providing strategic input and regulatory expertise to the project development plan and evaluate project risks and recommend regulatory mitigation
• Interacting with internal and external stakeholders and represent Regulatory Affairs in regulatory matters
• Being accountable for and developing regulatory documentation for submission to Health Authorities including meeting briefing packages, clinical trial applications, pediatrics plans, regulatory file for marketing authorization and response packages for Health Authorities Our commitment to innovation also applies to the way we work. We therefore embrace the hybrid workplace – with a blend of home office in Denmark and on-site office-based work in Søborg, Denmark where our team is based.
Qualifications
As an ideal candidate, you should have:
• A Master’s degree or PhD in life science or related field and an advanced level of written and spoken English
• At least, 5 years of regulatory device development experience in similar position, preferably from the pharmaceutical industry
• Proven track record of leadership, project management, stakeholder management and planning
• Hands-on experience navigating within an environment of tight timelines, high complexity, non-standards, and diverse tasks
• Strong IT/digital skills
• Experience of working on projects together with external collaborators is an advantage
As a person, you should be able to set clear directions and take the initiative to ensure tasks are completed efficiently. Additionally, you should be a team player who is willing to assist colleagues and work towards shared objectives. This means having an inclusive mindset and respecting the diversity of others. Demonstrating proactivity and employing excellent project management skills are essential to this role.
In addition to being flexible and change-oriented, you should enjoy experimenting and seeing opportunities in challenging situations. Finally, a good sense of humour and the ability to remain positive and motivated under pressure is considered an advantage.
About the department
RA Diabetes and Obesity Development Projects is responsible for the development of global regulatory strategies to advance projects within multiple indications from early stages of development to worldwide submission and approvals of initial Marketing Authorisation applications in close collaboration with our affiliates and global stakeholders.
This is an area that is expanding to more than 30 dedicated and highly engaged leads and regulatory professionals organized in 3 teams. We currently have multiple active projects covering a broad area, encompassing diverse domains, and functional areas of focus.
Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development to manufacturing, marketing, and sales – we’re all working to move the needle on patient care.
Contact
For further information, please contact David Truloff at [email protected].
Deadline
7 January 2024. We will review the applications on an ongoing basis, so we encourage you to apply as soon as possible.
To ensure an efficient and fair recruitment process, please refrain from adding a photo to your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
The position
As a Global Regulatory Lead, you will be overall accountable for developing and executing regulatory strategies with challenging and often overlapping timelines. You will lead regulatory matrix teams which includes leads from different areas within RA. You will collaborate with external collaborators that have a common interest in the project. The role offers breadth of responsibility, complexity, and organizational visibility, and you will have a lot of influence and impact on the project direction and decisions.
Your main responsibilities will be focused on:
• Representing Regulatory Affairs in Global Project Team
• Providing strategic input and regulatory expertise to the project development plan and evaluate project risks and recommend regulatory mitigation
• Interacting with internal and external stakeholders and represent Regulatory Affairs in regulatory matters
• Being accountable for and developing regulatory documentation for submission to Health Authorities including meeting briefing packages, clinical trial applications, pediatrics plans, regulatory file for marketing authorization and response packages for Health Authorities Our commitment to innovation also applies to the way we work. We therefore embrace the hybrid workplace – with a blend of home office in Denmark and on-site office-based work in Søborg, Denmark where our team is based.
Qualifications
As an ideal candidate, you should have:
• A Master’s degree or PhD in life science or related field and an advanced level of written and spoken English
• At least, 5 years of regulatory device development experience in similar position, preferably from the pharmaceutical industry
• Proven track record of leadership, project management, stakeholder management and planning
• Hands-on experience navigating within an environment of tight timelines, high complexity, non-standards, and diverse tasks
• Strong IT/digital skills
• Experience of working on projects together with external collaborators is an advantage
As a person, you should be able to set clear directions and take the initiative to ensure tasks are completed efficiently. Additionally, you should be a team player who is willing to assist colleagues and work towards shared objectives. This means having an inclusive mindset and respecting the diversity of others. Demonstrating proactivity and employing excellent project management skills are essential to this role.
In addition to being flexible and change-oriented, you should enjoy experimenting and seeing opportunities in challenging situations. Finally, a good sense of humour and the ability to remain positive and motivated under pressure is considered an advantage.
About the department
RA Diabetes and Obesity Development Projects is responsible for the development of global regulatory strategies to advance projects within multiple indications from early stages of development to worldwide submission and approvals of initial Marketing Authorisation applications in close collaboration with our affiliates and global stakeholders.
This is an area that is expanding to more than 30 dedicated and highly engaged leads and regulatory professionals organized in 3 teams. We currently have multiple active projects covering a broad area, encompassing diverse domains, and functional areas of focus.
Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development to manufacturing, marketing, and sales – we’re all working to move the needle on patient care.
Contact
For further information, please contact David Truloff at [email protected].
Deadline
7 January 2024. We will review the applications on an ongoing basis, so we encourage you to apply as soon as possible.
To ensure an efficient and fair recruitment process, please refrain from adding a photo to your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
Information og data
Denne ledige stilling har jobtypen "Apoteker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 19.12.2023, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Apoteker
- Søborg
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