Regulatory Affairs CMC Expert - Drug Substance
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Søborg
Are you passionate about drug development within RA CMC? Do you aspire to shape the future of global diabetes and obesity care as a subject matter expert in a leading international organization? If so, this is the ideal job for you. You will have the opportunity to take the lead and set the strategic direction in projects of crucial importance to ’s growth on a global level.Apply now for a life-changing career!
The position
As a Regulatory Affairs CMC Drug Substance Expert, you will support our diabetes and obesity portfolio by working on late-stage development and life-cycle management submissions worldwide. You will be the voice of Regulatory Affairs CMC, providing scientific and strategic input to obtain regulatory approvals. Your knowledge within pharmaceutical operations will be transformed into regulatory pathways, developing global regulatory CMC strategies based on current legislation and regulations.You will be in the center of project planning and execution – responsible for planning, coordinating, and reviewing regulatory documentation related to the drug substance e.g., supporting preparation of applicable sections of submission packages, responses to agency questions for global markets and Agency Meeting Packages.
More specifically, you will be accountable for:• Planning, executing and driving strategic regulatory CMC activities to ensure timely regulatory approvals and compliance
• Apply CMC regulatory intelligence to develop robust regulatory strategies
• Identifying as well as improving regulatory CMC practices, processes and approaches related to regulatory CMC documentation and strategies
Our commitment to innovation also applies to the way we work. We therefore embrace the hybrid workplace – with a blend of home office and on-site work preferably in Søborg, Denmark where the global RA CMC & Device department is based.
Qualifications
You come with a strong scientific and technical background and mindset, which you have acquired through your extensive experience with RA CMC and/or pharmaceutical operations – manufacturing, product supply, process development, CMC development, analytics, quality assurance and other related areas. The ideal candidate should have:Master’s degree and/or PhD in a relevant field Extensive experience from the pharmaceutical industry At least 8 years of relevant experience within Regulatory Affairs CMC. RA CMC experience working with drug substance in late development stages and with life cycle activities. High proficiency in English - written as well as spoken. Great communication skills as all work takes place in multidisciplinary project groups.
We expect you to be a person that comes with project management capabilities, a can-do mindset, and can navigate in uncertainty and help find ways forward. We also expect that you are a role-model for your team and our organization with your positive and professional behaviour. You are a dedicated team player, find it easy to build working relationships, and gain recognition amongst stakeholders with your proactiveness and integrity. Furthermore, you thrive in the challenging reality of international communication across time zones and cultures.About the department
Regulatory Affairs CMC & Device makes medicine available to patients around the world by ensuring fast regulatory submissions and approvals in all our global markets. The RA CMC Drug Substance team consists of 10 colleagues and is part of RA CMC Diabetes and Obesity department that consist of just over 70 highly skilled dedicated colleagues with very diverse backgrounds and experience, who are involved in every Regulatory CMC aspect concerning products and projects in these areas. As ’s product portfolio is growing, we are developing and implementing highly diverse CMC solutions to the complex manufacturing processes, therefore we are looking to expand our team.Working at
At , we do not wait for change. We drive it. We are 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 are all working to move the needle on patient care.
Contact
For more information regarding the role, you are welcome to contact Team Leader Mette Enghuus Jørgensen (+)
Deadline
22 April 2025.
If you are interested in this role, please apply as soon as possible. Applications will be evaluated on an ongoing basis, so there may go some time before you hear from us. 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.
The position
As a Regulatory Affairs CMC Drug Substance Expert, you will support our diabetes and obesity portfolio by working on late-stage development and life-cycle management submissions worldwide. You will be the voice of Regulatory Affairs CMC, providing scientific and strategic input to obtain regulatory approvals. Your knowledge within pharmaceutical operations will be transformed into regulatory pathways, developing global regulatory CMC strategies based on current legislation and regulations.You will be in the center of project planning and execution – responsible for planning, coordinating, and reviewing regulatory documentation related to the drug substance e.g., supporting preparation of applicable sections of submission packages, responses to agency questions for global markets and Agency Meeting Packages.
More specifically, you will be accountable for:• Planning, executing and driving strategic regulatory CMC activities to ensure timely regulatory approvals and compliance
• Apply CMC regulatory intelligence to develop robust regulatory strategies
• Identifying as well as improving regulatory CMC practices, processes and approaches related to regulatory CMC documentation and strategies
Our commitment to innovation also applies to the way we work. We therefore embrace the hybrid workplace – with a blend of home office and on-site work preferably in Søborg, Denmark where the global RA CMC & Device department is based.
Qualifications
You come with a strong scientific and technical background and mindset, which you have acquired through your extensive experience with RA CMC and/or pharmaceutical operations – manufacturing, product supply, process development, CMC development, analytics, quality assurance and other related areas. The ideal candidate should have:
We expect you to be a person that comes with project management capabilities, a can-do mindset, and can navigate in uncertainty and help find ways forward. We also expect that you are a role-model for your team and our organization with your positive and professional behaviour. You are a dedicated team player, find it easy to build working relationships, and gain recognition amongst stakeholders with your proactiveness and integrity. Furthermore, you thrive in the challenging reality of international communication across time zones and cultures.About the department
Regulatory Affairs CMC & Device makes medicine available to patients around the world by ensuring fast regulatory submissions and approvals in all our global markets. The RA CMC Drug Substance team consists of 10 colleagues and is part of RA CMC Diabetes and Obesity department that consist of just over 70 highly skilled dedicated colleagues with very diverse backgrounds and experience, who are involved in every Regulatory CMC aspect concerning products and projects in these areas. As ’s product portfolio is growing, we are developing and implementing highly diverse CMC solutions to the complex manufacturing processes, therefore we are looking to expand our team.Working at
At , we do not wait for change. We drive it. We are 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 are all working to move the needle on patient care.
Contact
For more information regarding the role, you are welcome to contact Team Leader Mette Enghuus Jørgensen (+)
Deadline
22 April 2025.
If you are interested in this role, please apply as soon as possible. Applications will be evaluated on an ongoing basis, so there may go some time before you hear from us. 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 5.2.2025, 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.
- 01.04.2025
- Apoteker
- Søborg
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