Senior Regulatory Professional within rare disease drug development
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Søborg
Do you want to become part of an exciting environment where engaged people are committed to gain approval of ’s medicines by regulatory authorities across the globe?
If yes, join Regulatory Affairs (RA). 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.
This position offers a lifetime experience in terms of drug development - a culmination of many years of research and development, the current focus is the creation of a regulatory file with the purpose of obtaining marketing authorisation on a global scale and serving the patients with better treatments.
The position
As a Senior Regulatory Professional, you will be responsible for driving several regulatory tasks with challenging and often overlapping timelines. You will be a member of cross functional project and submission teams, and as such, interact with a variety of stakeholders from different departments in .
Your main responsibilities will be focused on: Being responsible for the development of regulatory documentation for submission to health authorities, including information packages for authority meetings, response packages for health authorities, and regulatory file for marketing authorisation Contributing to the global regulatory strategies and tactics, be proactive and bold, challenge the discussions and contribute to project team decisions Interacting with project management, medical and non-clinical specialists, statisticians, and medical writers Being part of the team clinical trial team responsible for clinical trial applications, amendments, and clinical trial reports
Specifically, for this job you will get the opportunity to be part of a team who right now are in phase 3 with a rare disease and soon will be facing a very exciting period of authority interactions and planning for obtaining the regulatory approval.
You will report to the Senior Director of RA Rare Bleeding Disorders and take active part in department related activities, including improvement projects across RA.
Qualifications
To be a competitive candidate, you should have: Bachelor’s or master’s degree related to Life Science, Engineering or similar At least, 4-5 years of regulatory or drug development experience Communication skills to collaborate as a strategic business partner at any organisational level Professional proficiency in English As a person you thrive in a fast-paced work environment with unfamiliar situations. You bring a can-do spirit and a healthy sense of humor to your work. You are a flexible and change-oriented person who likes to experiment and sees opportunities rather than limitations in challenging situations. It is important for you to feel that you are part of a team and an active contributor to the success of the team.
About the department
RA Rare Bleeding Disorders department is part of Global Regulatory Affairs and situated in Søborg, Denmark. We are contributing to the development of different products and projects within Rare Bleeding Disorders with a pipeline including a variety of different modalities and technologies including gene therapy.
We are a department with 14 dedicated and highly engaged employees of 8 different nationalities with diverse backgrounds and experiences. We work in a flexible set-up where trust & openness, sparring, challenge and knowledge sharing fosters an inclusive and innovative culture we all enjoy being part of.
We work as an integrated part of the global development, research project teams and cross-functional sub-teams. We are responsible for the regulatory strategies and provide regulatory expertise and tactics to the product development plan. We drive product labelling, Health Authority interactions and clinical trial applications. We have a strong collaboration with our stakeholders in affiliates and work in global regulatory matrix teams with colleagues from RA CMC, RA device, US etc., who all have important roles and contributions, and together form a team with the capacity to execute ambitions plans. Working at
At , 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 necessary 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, through to manufacturing, marketing, and sales – we’re all working to move the needle on patient care.
Contact
For further information, please contact Senior Director Jane Møll Pedersen at +. Deadline
7 April 2024.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At 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 yes, join Regulatory Affairs (RA). 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.
This position offers a lifetime experience in terms of drug development - a culmination of many years of research and development, the current focus is the creation of a regulatory file with the purpose of obtaining marketing authorisation on a global scale and serving the patients with better treatments.
The position
As a Senior Regulatory Professional, you will be responsible for driving several regulatory tasks with challenging and often overlapping timelines. You will be a member of cross functional project and submission teams, and as such, interact with a variety of stakeholders from different departments in .
Your main responsibilities will be focused on:
Specifically, for this job you will get the opportunity to be part of a team who right now are in phase 3 with a rare disease and soon will be facing a very exciting period of authority interactions and planning for obtaining the regulatory approval.
You will report to the Senior Director of RA Rare Bleeding Disorders and take active part in department related activities, including improvement projects across RA.
Qualifications
To be a competitive candidate, you should have:
About the department
RA Rare Bleeding Disorders department is part of Global Regulatory Affairs and situated in Søborg, Denmark. We are contributing to the development of different products and projects within Rare Bleeding Disorders with a pipeline including a variety of different modalities and technologies including gene therapy.
We are a department with 14 dedicated and highly engaged employees of 8 different nationalities with diverse backgrounds and experiences. We work in a flexible set-up where trust & openness, sparring, challenge and knowledge sharing fosters an inclusive and innovative culture we all enjoy being part of.
We work as an integrated part of the global development, research project teams and cross-functional sub-teams. We are responsible for the regulatory strategies and provide regulatory expertise and tactics to the product development plan. We drive product labelling, Health Authority interactions and clinical trial applications. We have a strong collaboration with our stakeholders in affiliates and work in global regulatory matrix teams with colleagues from RA CMC, RA device, US etc., who all have important roles and contributions, and together form a team with the capacity to execute ambitions plans. Working at
At , 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 necessary 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, through to manufacturing, marketing, and sales – we’re all working to move the needle on patient care.
Contact
For further information, please contact Senior Director Jane Møll Pedersen at +. Deadline
7 April 2024.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At 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 22.3.2024, 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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