Regulatory Affairs Specialist, Obesity
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Søborg
Do you want to be part of an exciting environment where engaged people are committed to optimize ’s medicines across the globe? Would you like to have a key role in ensuring that life-changing medicines reach more patients globally?
If yes, join us! We are looking for a Regulatory Specialist in the Obesity team!
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. The position
As Regulatory Affairs Specialist, you will be responsible for developing regulatory strategies and lead their execution via interaction with cross-functional teams. You will lead, drive, and coordinate several regulatory activities related to optimizing delivery solutions for the GLP-1 portfolio. This will entail close collaboration with the Global Regulatory Leads.
Your main responsibilities will include the following:
• Contribute with regulatory expertise to global strategies and tactics, by providing your specialist knowledge via analysing regulatory opportunities and risks
• Lead major submission tracks such as briefing packages for meetings with Health Authorities, and global submission strategies, working with affiliates to ensure alignment between local and global regulatory strategies and timely preparation of documentation
You will report to the Senior Director of RA SEMA Obesity and take active part in department related activities, including improvement projects across RA.
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:
• Master’s degree or Ph.D. in science, pharmaceutical or health science
• At least, 6 years of experience in Regulatory Affairs or any other relevant area in drug development
• Experience working in a pharmaceutical company and/or regulatory authority
• Practical knowledge in defining and developing global regulatory strategies and good all-around understanding of the regulatory documentation and requirements for pharmaceutical development and licensing.
• Experience with drug-device combination products and device or development of other delivery solutions from a drug perspective will be an advantage
• Ability to communicate in fluent English (both written and spoken) We are looking for a person who is comfortable speaking their mind, enjoys a challenging problem and has a strong personal drive with the ability to keep your spirit high under pressure. You have a professional and personal impact that is reflected in your desire to take initiative and finally, you must have a willingness to take responsibility for your own learning. On a personal level you bring a can-do attitude and demonstrate a flexible, change-oriented approach, you demonstrate proactivity and employ excellent project management skills. You have a willingness to experiment and a tendency to view challenging situations as opportunities rather than limitations and you are a skilled communicator who can cooperate at any organisational level.
About the department
RA SEMA Obesity is responsible for defining and driving regulatory strategies within the weight management portfolio. We are 10 dedicated and highly engaged employees in the department belonging to the RA SEMA 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 regulatory strategy and provide regulatory expertise and tactics to the product development plans. We drive label development, health authority interactions and global submission strategies. We have a strong collaboration with our affiliates and global stakeholders in the regulatory teams. 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 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, 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, Trine Kruse at +. Deadline
14 April 2024.
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 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 us! We are looking for a Regulatory Specialist in the Obesity team!
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. The position
As Regulatory Affairs Specialist, you will be responsible for developing regulatory strategies and lead their execution via interaction with cross-functional teams. You will lead, drive, and coordinate several regulatory activities related to optimizing delivery solutions for the GLP-1 portfolio. This will entail close collaboration with the Global Regulatory Leads.
Your main responsibilities will include the following:
• Contribute with regulatory expertise to global strategies and tactics, by providing your specialist knowledge via analysing regulatory opportunities and risks
• Lead major submission tracks such as briefing packages for meetings with Health Authorities, and global submission strategies, working with affiliates to ensure alignment between local and global regulatory strategies and timely preparation of documentation
You will report to the Senior Director of RA SEMA Obesity and take active part in department related activities, including improvement projects across RA.
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:
• Master’s degree or Ph.D. in science, pharmaceutical or health science
• At least, 6 years of experience in Regulatory Affairs or any other relevant area in drug development
• Experience working in a pharmaceutical company and/or regulatory authority
• Practical knowledge in defining and developing global regulatory strategies and good all-around understanding of the regulatory documentation and requirements for pharmaceutical development and licensing.
• Experience with drug-device combination products and device or development of other delivery solutions from a drug perspective will be an advantage
• Ability to communicate in fluent English (both written and spoken) We are looking for a person who is comfortable speaking their mind, enjoys a challenging problem and has a strong personal drive with the ability to keep your spirit high under pressure. You have a professional and personal impact that is reflected in your desire to take initiative and finally, you must have a willingness to take responsibility for your own learning. On a personal level you bring a can-do attitude and demonstrate a flexible, change-oriented approach, you demonstrate proactivity and employ excellent project management skills. You have a willingness to experiment and a tendency to view challenging situations as opportunities rather than limitations and you are a skilled communicator who can cooperate at any organisational level.
About the department
RA SEMA Obesity is responsible for defining and driving regulatory strategies within the weight management portfolio. We are 10 dedicated and highly engaged employees in the department belonging to the RA SEMA 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 regulatory strategy and provide regulatory expertise and tactics to the product development plans. We drive label development, health authority interactions and global submission strategies. We have a strong collaboration with our affiliates and global stakeholders in the regulatory teams. 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 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, 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, Trine Kruse at +. Deadline
14 April 2024.
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 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 26.3.2024, 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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