Global Regulatory Lead for late-stage development project
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Søborg
Would you like to have a key role executing the strategy for ensuring the successful filing to obtain Marketing Authorisation? If yes, join our esteemed Regulatory Affairs (RA) area as a Global Regulatory Lead and contribute to an exhilarating and dynamic organization. At our company, we are dedicated to obtaining Marketing Authorisations for innovative medicines from regulatory authorities worldwide.
Don't miss this opportunity and apply now!
The position
As a Global Regulatory Lead, you will be a regulatory specialist overall accountable for developing and executing regulatory strategies with challenging and often overlapping timelines for a late-stage development project, soon approaching filing of a Marketing Authorisation Application. You will act as informal leader for a large regulatory matrix team to ensure timely and high-quality regulatory deliverables to the global project teams. The role offers great breadth of responsibility, complexity, organizational visibility, and development opportunities, and you will have a lot of influence and impact on the project direction and decisions. Your main responsibilities will be focused on:
• Representing Global 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 Global Regulatory Affairs in regulatory matters
• Leading interactions with Health Authorities
• Being accountable for and developing regulatory documentation for submission to Health Authorities including meeting briefing packages, regulatory file for marketing authorisation 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
To be a competitive candidate, you should have:
• A master’s degree or PhD in life science or similar and professional proficiency in English
• At least, 5 years of regulatory or drug development experience in similar position, preferably from the pharmaceutical industry or Health Authority
• Experience of working on projects in late-stage development phase and submission experience is an advantage
• 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
You will report to the team leader of RA Diabetes & Obesity Development Project II and take active part in department related activities. Demonstrating proactivity and employing excellent project management skills are essential to this role. You should be able to set clear direction 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.
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 & 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 consists of more than 30 dedicated and highly engaged regulatory professionals and leads 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 Jenny Kastberg on [email protected].
Deadline
1 January 2024 We will review the applications and start with interviews 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.
Don't miss this opportunity and apply now!
The position
As a Global Regulatory Lead, you will be a regulatory specialist overall accountable for developing and executing regulatory strategies with challenging and often overlapping timelines for a late-stage development project, soon approaching filing of a Marketing Authorisation Application. You will act as informal leader for a large regulatory matrix team to ensure timely and high-quality regulatory deliverables to the global project teams. The role offers great breadth of responsibility, complexity, organizational visibility, and development opportunities, and you will have a lot of influence and impact on the project direction and decisions. Your main responsibilities will be focused on:
• Representing Global 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 Global Regulatory Affairs in regulatory matters
• Leading interactions with Health Authorities
• Being accountable for and developing regulatory documentation for submission to Health Authorities including meeting briefing packages, regulatory file for marketing authorisation 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
To be a competitive candidate, you should have:
• A master’s degree or PhD in life science or similar and professional proficiency in English
• At least, 5 years of regulatory or drug development experience in similar position, preferably from the pharmaceutical industry or Health Authority
• Experience of working on projects in late-stage development phase and submission experience is an advantage
• 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
You will report to the team leader of RA Diabetes & Obesity Development Project II and take active part in department related activities. Demonstrating proactivity and employing excellent project management skills are essential to this role. You should be able to set clear direction 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.
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 & 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 consists of more than 30 dedicated and highly engaged regulatory professionals and leads 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 Jenny Kastberg on [email protected].
Deadline
1 January 2024 We will review the applications and start with interviews 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 15.12.2023, 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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