Senior Regulatory Professional for innovative medicines in clinical development
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Søborg
Do you want to play a key role in accelerating the development of our patient-focused products? Are you passionate about regulatory science and executing on regulatory strategies to bring innovative medicines to patients?
If so, we invite you to become a part of our dynamic and forward-looking regulatory organisation. We are expanding our team of highly engaged professionals who play pivotal roles in developing medical solutions and obtaining approvals from regulatory authorities worldwide.
Apply now and join us in this exciting journey!
The position
As a Senior Regulatory Affairs Professional, collaborate closely with the Global Regulatory Lead and a team of regulatory professionals, working together to advance Phase II projects within multiple therapy areas of obesity, diabetes, and other related conditions.
You will be an integral member of and potentially lead cross-functional project teams, including study groups, submission team and task specific working groups which can include activities such as PIP/PSP development, labelling, applications for expedite pathways and interactions with health authorities.
Your key responsibilities will be focused on: Contributing with regulatory expertise to global strategies and tactics Participating in the development of regulatory documentation, such as briefing packages for Health Authority meetings, clinical trial applications, protocols and reports, paediatric development plans, and labelling Ensuring the timely submission of clinical trial applications to advance the clinical programme Working with regulatory colleagues, project management, medical and non-medical specialists, statisticians, and medical writers, providing regulatory input and contributing to project decisions Being involved in establishing internal positions on regulatory issues, new and changing guidelines, and improvement projects across Regulatory Affairs Our commitment to innovation also applies to the way we work. We therefore embrace the hybrid workplace – with a blend of on-site office-based work in Søborg, Denmark where our team is based and home office in Denmark. Qualifications
We expect an ideal candidate to have the following: Master's degree within Life Science, Health Science, or a related field 4-5 years of experience within Regulatory Affairs in clinical drug development or life cycle management Track record or keen interest in therapeutic areas would be an advantage Strong IT/digital skills Fluency in written and spoken English
As person, you thrive in team environments and actively contribute to their team's success. You should be well-organised, possess robust problem-solving capabilities, and maintain a strategic focus. A positive, can-do attitude is crucial, as is the ability to keep your spirits high and maintain a healthy sense of humour under pressure. Effective communication skills that enable cooperation at all organisational levels are highly valued. About the department
RA Obesity and Liver is a new and expanding area and will soon be 25 dedicated and highly engaged Managers, Global Regulatory leads, specialists, and regulatory professionals, organised into three teams. We are currently managing multiple active projects that span a wide array of domains and functional areas.
Our department is charged with delivering and executing global regulatory strategies. These strategies are designed to advance projects across multiple indications, from the early stages of development through to worldwide submission and approval of initial Marketing Authorisation applications.
We are responsible for driving regulatory strategy, label development, facilitating interactions with health authorities, and overseeing regulatory submissions. These submissions include initial marketing authorisation applications, pediatric plans, and clinical trial applications. We maintain strong ties with our affiliates and global stakeholders, fostering a close collaboration that is integral to our operations. 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 +45 3079 0499. Deadline
18 March 2024. By submitting your application for this position, you acknowledge and agree that your CV and application materials may be accessible and viewed by relevant managers within our organization for the purpose of evaluating your candidacy. Please note we will invite candidates for interviews on an ongoing basis and conclude the recruitment process when the right candidate has been found. You do not need to attach a cover letter to your application, but please include a few lines about your motivation in your resume or CV. Please assist us in maintaining a fair and inclusive selection process by not attaching a photo to your application. 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.
If so, we invite you to become a part of our dynamic and forward-looking regulatory organisation. We are expanding our team of highly engaged professionals who play pivotal roles in developing medical solutions and obtaining approvals from regulatory authorities worldwide.
Apply now and join us in this exciting journey!
The position
As a Senior Regulatory Affairs Professional, collaborate closely with the Global Regulatory Lead and a team of regulatory professionals, working together to advance Phase II projects within multiple therapy areas of obesity, diabetes, and other related conditions.
You will be an integral member of and potentially lead cross-functional project teams, including study groups, submission team and task specific working groups which can include activities such as PIP/PSP development, labelling, applications for expedite pathways and interactions with health authorities.
Your key responsibilities will be focused on:
We expect an ideal candidate to have the following:
As person, you thrive in team environments and actively contribute to their team's success. You should be well-organised, possess robust problem-solving capabilities, and maintain a strategic focus. A positive, can-do attitude is crucial, as is the ability to keep your spirits high and maintain a healthy sense of humour under pressure. Effective communication skills that enable cooperation at all organisational levels are highly valued. About the department
RA Obesity and Liver is a new and expanding area and will soon be 25 dedicated and highly engaged Managers, Global Regulatory leads, specialists, and regulatory professionals, organised into three teams. We are currently managing multiple active projects that span a wide array of domains and functional areas.
Our department is charged with delivering and executing global regulatory strategies. These strategies are designed to advance projects across multiple indications, from the early stages of development through to worldwide submission and approval of initial Marketing Authorisation applications.
We are responsible for driving regulatory strategy, label development, facilitating interactions with health authorities, and overseeing regulatory submissions. These submissions include initial marketing authorisation applications, pediatric plans, and clinical trial applications. We maintain strong ties with our affiliates and global stakeholders, fostering a close collaboration that is integral to our operations. 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 +45 3079 0499. Deadline
18 March 2024. By submitting your application for this position, you acknowledge and agree that your CV and application materials may be accessible and viewed by relevant managers within our organization for the purpose of evaluating your candidacy. Please note we will invite candidates for interviews on an ongoing basis and conclude the recruitment process when the right candidate has been found. You do not need to attach a cover letter to your application, but please include a few lines about your motivation in your resume or CV. Please assist us in maintaining a fair and inclusive selection process by not attaching a photo to your application. 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 17.2.2024, 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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