Global Regulatory Affairs Supply Lead - Project Manager
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Søborg
Would you like to have the opportunity to work in an innovative and strategic Regulatory Affairs (RA) area? Do you want to be part of a new team that is growing?
We have recently created a Drug Shortage Unit within Global RA under Global RA Semaglutide and GLP-1 and are actively searching for a Global Regulatory Affairs Supply Lead to be part of the team to champion pivotal initiatives. If this aligns with your career aspirations and experience, we encourage you to submit your application today!
The position
As a Global Regulatory Affairs Supply Lead, you will be responsible for driving several regulatory tasks with challenging and often overlapping timelines. Your key responsibility will be to lead LCM activities related to medicines supply from Regulatory Affairs in cross functional teams.
Your main tasks will include: Lead initiatives from Regulatory Affairs to support regulatory communication about drug shortages and medicines supply Champion regulatory compliance to drug shortage and supply requirements Provide regulatory input, to key cross-functional stakeholders in supply chain, commercial, communication, legal, safety and RA Ensure regulatory alignment between affiliate and global stakeholder including systems compliance
Qualifications
To be a competitive candidate you should have: A MSc degree related to Life Science, pharmaceutical science, or a related field Extensive experience within regulatory affairs or related disciplines in the pharma industry, including experience with major health authorities such as FDA or EMA Expertise in drug supply Strong project management skills Strong competence in regulatory intelligence and lifecycle management (LCM) Good communication skills in English to collaborate as a strategic business partner at any organizational level
As a person you thrive in a fast-paced working environment with unfamiliar situations. You bring strong planning and problem-solving skills, excellent stakeholder management, innovative thinking, and are a flexible, and change-oriented person who sees opportunities in challenging situations. About the department
RA Semaglutide & GLP-1 is responsible for defining and driving regulatory strategies for our Semaglutide and GLP-1 portfolio projects in all phases of development. We are dedicated and highly engaged employees in the department belonging to the RA Semaglutide & GLP-1 area. We work as an integrated part of the global development and research projects and play a key role in the cross-functional teams. Our department is responsible for Semaglutide and Liraglutide regulatory strategies 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
At , we do not 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 Drug Shortage RA director Camilla Jacobsen, +. Deadline
31 March 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.
We have recently created a Drug Shortage Unit within Global RA under Global RA Semaglutide and GLP-1 and are actively searching for a Global Regulatory Affairs Supply Lead to be part of the team to champion pivotal initiatives. If this aligns with your career aspirations and experience, we encourage you to submit your application today!
The position
As a Global Regulatory Affairs Supply Lead, you will be responsible for driving several regulatory tasks with challenging and often overlapping timelines. Your key responsibility will be to lead LCM activities related to medicines supply from Regulatory Affairs in cross functional teams.
Your main tasks will include:
Qualifications
To be a competitive candidate you should have:
As a person you thrive in a fast-paced working environment with unfamiliar situations. You bring strong planning and problem-solving skills, excellent stakeholder management, innovative thinking, and are a flexible, and change-oriented person who sees opportunities in challenging situations. About the department
RA Semaglutide & GLP-1 is responsible for defining and driving regulatory strategies for our Semaglutide and GLP-1 portfolio projects in all phases of development. We are dedicated and highly engaged employees in the department belonging to the RA Semaglutide & GLP-1 area. We work as an integrated part of the global development and research projects and play a key role in the cross-functional teams. Our department is responsible for Semaglutide and Liraglutide regulatory strategies 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
At , we do not 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 Drug Shortage RA director Camilla Jacobsen, +. Deadline
31 March 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 13.3.2024, 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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