Regulatory Affairs Senior Director
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Søborg
Are you looking to develops regulatory submission strategies and ensures alignment across Semaglutide Outcome Trials? Do you thrive in several job areas across functions and would like to own an in-depth knowledge of organisational objectives?
Then you may be the right fit to become our new Senior Director and join Semaglutide Global Regulatory Affairs team in Søborg/Copenhagen. Read more and apply!
The position
As a Senior Director, you will leverage the key learnings and strategic approach of integrating Real World Data/Evidence (RWD/E) to support the development projects, regulatory decision-making, and labelling. In this position you will represent Global regulatory affairs (GRA) in Novo Nordisk RWD/E & Cardiovascular Outcome Trial (CVOT) fora and projects, as well as external platforms to increase NN share of voice in shaping the RWD/E RA landscape. Among your main tasks, you will:
• Develop regulatory RWD/E and outcome strategies across portfolio
• Plan and conduct of regulatory RWD/E and Semaglutide Outcome Trials’ interactions with health authorities
• Support projects to prepare and submit of regulatory RWD/E related files and response to questions from health authorities • Ensure Regulatory RWD/E and Outcome trials skills and capabilities are developed in GRA in line with the projects and business needs and requirements
• Provide training to GRA, help building the needed competencies and share lessons learned/best practice across GRA This role requires strong leadership, scientific presence and great stakeholder management, in order to communicate timely with various cross/functional teams and departments as well as regulators and external partners. In fact, you will represent GRA at various Development, cross-functional and external platforms for RWD/E and CVOT’s. Qualifications
We are looking for someone that has solid knowledge in Regulatory science, clinical development, data generation, medical and disease area understanding and ability to interpret clinical data and build strong regulatory science strategies and submission scenarios. You also have solid knowledge and competencies in regulatory early and late-stage development, LCM, health authority interaction, regulatory intelligence and device development. To succeed in this role, you:
• Have an educational background as MD., PharmD., or PhD
• Have 10+ years of experience within clinical trials or regulatory affairs
• Have proven experience as a project manager and line manager
• Have strong stakeholder management and networking skills
• Are fluent in written and spoken English On a personal level, you demonstrate proactive leadership style and act with a committed, persistent and accountable behaviour. Your strong change management skills, as well as planning and coordination skills, help you to identify problems and solutions proactively – keeping things simple and eliminate unnecessary complexity. As a leader you delegate and empower to encourage others to take action, also by actively coaching and providing feedback. Your inclusive mindset will allow you to build trust and relationships across functions and cultures. About the department
RA Semaglutide is responsible for defining and driving regulatory strategies for our Semaglutide projects in all phases of development. We are dedicated and highly engaged employees in the department belonging to the RA Semaglutide area. We work as an integrated part of the global development and research projects and play a key role in the cross-functional teams. We are responsible for the Semaglutide regulatory strategy and provide regulatory expertise and tactics to the product development plans. We drive label development, health authority interactions and clinical trial applications. We have a strong collaboration with our affiliates and global stakeholders in the regulatory teams.
Working at Novo Nordisk
We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease.
Contact
In case of further questions please contact Emel Mashaki Ceyhan at +4534481007
Deadline
17 February 2023
You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in 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.
Then you may be the right fit to become our new Senior Director and join Semaglutide Global Regulatory Affairs team in Søborg/Copenhagen. Read more and apply!
The position
As a Senior Director, you will leverage the key learnings and strategic approach of integrating Real World Data/Evidence (RWD/E) to support the development projects, regulatory decision-making, and labelling. In this position you will represent Global regulatory affairs (GRA) in Novo Nordisk RWD/E & Cardiovascular Outcome Trial (CVOT) fora and projects, as well as external platforms to increase NN share of voice in shaping the RWD/E RA landscape. Among your main tasks, you will:
• Develop regulatory RWD/E and outcome strategies across portfolio
• Plan and conduct of regulatory RWD/E and Semaglutide Outcome Trials’ interactions with health authorities
• Support projects to prepare and submit of regulatory RWD/E related files and response to questions from health authorities • Ensure Regulatory RWD/E and Outcome trials skills and capabilities are developed in GRA in line with the projects and business needs and requirements
• Provide training to GRA, help building the needed competencies and share lessons learned/best practice across GRA This role requires strong leadership, scientific presence and great stakeholder management, in order to communicate timely with various cross/functional teams and departments as well as regulators and external partners. In fact, you will represent GRA at various Development, cross-functional and external platforms for RWD/E and CVOT’s. Qualifications
We are looking for someone that has solid knowledge in Regulatory science, clinical development, data generation, medical and disease area understanding and ability to interpret clinical data and build strong regulatory science strategies and submission scenarios. You also have solid knowledge and competencies in regulatory early and late-stage development, LCM, health authority interaction, regulatory intelligence and device development. To succeed in this role, you:
• Have an educational background as MD., PharmD., or PhD
• Have 10+ years of experience within clinical trials or regulatory affairs
• Have proven experience as a project manager and line manager
• Have strong stakeholder management and networking skills
• Are fluent in written and spoken English On a personal level, you demonstrate proactive leadership style and act with a committed, persistent and accountable behaviour. Your strong change management skills, as well as planning and coordination skills, help you to identify problems and solutions proactively – keeping things simple and eliminate unnecessary complexity. As a leader you delegate and empower to encourage others to take action, also by actively coaching and providing feedback. Your inclusive mindset will allow you to build trust and relationships across functions and cultures. About the department
RA Semaglutide is responsible for defining and driving regulatory strategies for our Semaglutide projects in all phases of development. We are dedicated and highly engaged employees in the department belonging to the RA Semaglutide area. We work as an integrated part of the global development and research projects and play a key role in the cross-functional teams. We are responsible for the Semaglutide regulatory strategy and provide regulatory expertise and tactics to the product development plans. We drive label development, health authority interactions and clinical trial applications. We have a strong collaboration with our affiliates and global stakeholders in the regulatory teams.
Working at Novo Nordisk
We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease.
Contact
In case of further questions please contact Emel Mashaki Ceyhan at +4534481007
Deadline
17 February 2023
You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in 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 "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 23.1.2023, 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.
- Øvrige
- Søborg
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