Regulatory Affairs Specialist
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Søborg
Are you passionate about ensuring regulatory compliance for new products and product amendments? Do you thrive in a dynamic and challenging environment? We are looking for a Regulatory Affairs Specialist to join our Global Regulatory Affairs team at . If you are ready for a life-changing opportunity, apply today! The position
As Regulatory Affairs Specialist, you will be responsible for developing regulatory strategies and lead their execution via interactions with cross-functional teams. This will entail close collaboration with the Global Regulatory Lead. You will drive and coordinate several regulatory activities with challenging and often overlapping timelines and be a member of cross functional project teams, and as such interact with a variety of stakeholders from different departments in . Your tasks will include the following: Contribute with regulatory expertise to global strategies and tactics, specifically Japan and China, by providing your specialist knowledge via analysing regulatory opportunities and risks Drive the development of regulatory documentation for submission to Health Authorities, including briefing packages for meetings with Health Authorities and clinical trial applications Take the lead on major submission tracks as submission country lead, where you will be working with stakeholders in affiliates to ensure alignment between local and global regulatory strategies and timely preparation of regulatory documentation Provide regulatory input, be proactive, challenge the discussions and contribute to project team decisions Interact with project management, medical and non-clinical specialists, statisticians, and medical writers. You will report to the Team Leader of RA CagriSema Obesity & Amylin and actively participate in department-related activities, including improvement projects across Regulatory Affairs. Qualifications
We expect you to have: Master's degree within Life Science, Health Science, or a related field At least 7-8 years of experience in Regulatory Affairs or other relevant area in drug development 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 regulatory authority interactions on an international scale Strong IT/digital skills Fluent written and spoken English Personally, 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 CagriSema Obesity & Amylin currently consists of 14 dedicated and highly engaged employees. Our department is responsible for the development of global regulatory strategies to advance the project from early stages of development to worldwide submission and approvals of initial Marketing Authorisation applications. We work as an integrated part of the global development organisation and play a key role in the cross-functional teams. We are responsible for the development, implementation and execution of global regulatory strategies and regulatory operational activities in alignment with the global project development plan. We drive label development, health authority interactions and regulatory submissions, hereunder initial marketing authorisation applications, paediatric plans, and clinical trial applications. We have a close collaboration with our affiliates and global stakeholders. 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 to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. Contact
For further information, please contact Christina Winther Poulsen, Regulatory Affairs Team Leader at Deadline
01 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.
As Regulatory Affairs Specialist, you will be responsible for developing regulatory strategies and lead their execution via interactions with cross-functional teams. This will entail close collaboration with the Global Regulatory Lead. You will drive and coordinate several regulatory activities with challenging and often overlapping timelines and be a member of cross functional project teams, and as such interact with a variety of stakeholders from different departments in . Your tasks will include the following:
We expect you to have:
RA CagriSema Obesity & Amylin currently consists of 14 dedicated and highly engaged employees. Our department is responsible for the development of global regulatory strategies to advance the project from early stages of development to worldwide submission and approvals of initial Marketing Authorisation applications. We work as an integrated part of the global development organisation and play a key role in the cross-functional teams. We are responsible for the development, implementation and execution of global regulatory strategies and regulatory operational activities in alignment with the global project development plan. We drive label development, health authority interactions and regulatory submissions, hereunder initial marketing authorisation applications, paediatric plans, and clinical trial applications. We have a close collaboration with our affiliates and global stakeholders. 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 to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. Contact
For further information, please contact Christina Winther Poulsen, Regulatory Affairs Team Leader at Deadline
01 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 5.2.2024, 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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