Regulatory Professional for CMC
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Hørsholm
The job
We are looking for a passionate colleague to manage our regulatory chemistry, manufacture and control (CMC) activities for our strategic tablet products registered globally.
You will join the Regulatory CMC, Tablets and Next Generation team consisting of 10 employees based at our Head Office in Hørsholm, Denmark. The team forms part of the Global Regulatory Affairs function within ALK.
In this role you will be responsible for:
Your profile
You have a Master of Science, (e.g., in pharmacy, engineering or another relevant discipline), working experience with regulatory CMC submissions and a basic knowledge of the pharmaceutical industry and GMP.
You thrive in scientific discussions with the goal of clarifying needs and identifying solutions you are well structured and you enjoy preparing clear and logically organised written material on complex scientific matters. As there are several parallel activities and deadlines to manage in your role, your strong planning skills will also come into play.
You take responsibility for getting the job done, are results oriented and are able to keep the perspective in times of increased activity.
Furthermore, you possess excellent communication and stakeholder management skills, and you master English at a high professional level, both in writing and orally.
We offer
In Global Regulatory Affairs, we provide an attractive working environment for candidates looking for both personal and professional development.
ALK provides a uniquely dynamic and pleasant work environment, complete with inspiring and challenging assignments. By joining ALK you will get the opportunity to be part of our exciting journey where you are creating results and developing solutions together with highly skilled and engaged colleagues while helping millions of people suffering with allergy.
You will be part of an engaged and informal team who values your skills and creativity, where the working environment is informal and flexible. Sharing learnings within the team is very important for us and we consider our pioneering spirit, coupled with our trustworthiness, our winning formula.
Application deadline
The application process will close on 21 August 2023.
If you want to learn more about our company, we encourage you to visit us at www.alk.net.
We are looking for a passionate colleague to manage our regulatory chemistry, manufacture and control (CMC) activities for our strategic tablet products registered globally.
You will join the Regulatory CMC, Tablets and Next Generation team consisting of 10 employees based at our Head Office in Hørsholm, Denmark. The team forms part of the Global Regulatory Affairs function within ALK.
In this role you will be responsible for:
- Preparing regulatory CMC documentation and handling submissions to authorities
- Scientific/technical writing and maintaining regulatory CMC documentation for initial and life cycle submissions for strategic products
- Having an overview of submitted and approved CMC documentation globally
- Ensuring cross-functional and external cooperation related to product life cycle activities
- Communicating, coordinating, negotiating and aligning regulatory strategies as representative for regulatory CMC in regulatory working groups and cross-functional project teams
- Taking on regulatory responsibility for compiling the CMC part of global applications and running life cycle submissions
- Establishing the right strategy for CMC documentation and submission
- Evaluating regulatory impact for CMC changes
- Providing regulatory guidance for various cross-functional areas
- Monitoring global regulatory requirements and conducting regulatory impact assessment related to CMC
Your profile
You have a Master of Science, (e.g., in pharmacy, engineering or another relevant discipline), working experience with regulatory CMC submissions and a basic knowledge of the pharmaceutical industry and GMP.
You thrive in scientific discussions with the goal of clarifying needs and identifying solutions you are well structured and you enjoy preparing clear and logically organised written material on complex scientific matters. As there are several parallel activities and deadlines to manage in your role, your strong planning skills will also come into play.
You take responsibility for getting the job done, are results oriented and are able to keep the perspective in times of increased activity.
Furthermore, you possess excellent communication and stakeholder management skills, and you master English at a high professional level, both in writing and orally.
We offer
In Global Regulatory Affairs, we provide an attractive working environment for candidates looking for both personal and professional development.
ALK provides a uniquely dynamic and pleasant work environment, complete with inspiring and challenging assignments. By joining ALK you will get the opportunity to be part of our exciting journey where you are creating results and developing solutions together with highly skilled and engaged colleagues while helping millions of people suffering with allergy.
You will be part of an engaged and informal team who values your skills and creativity, where the working environment is informal and flexible. Sharing learnings within the team is very important for us and we consider our pioneering spirit, coupled with our trustworthiness, our winning formula.
Application deadline
The application process will close on 21 August 2023.
If you want to learn more about our company, we encourage you to visit us at www.alk.net.
Information og data
Denne ledige stilling har jobtypen "Apoteker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Hørsholm.
Jobbet er oprettet på vores service den 24.7.2023, 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
- Hørsholm
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Statistik over udbudte jobs som apotekere i Hørsholm
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Statistik over udbudte apotekere i Hørsholm over tid
| Dato | Alle jobs som apotekere |
|---|---|
| 11. januar 2025 | 2 |
| 10. januar 2025 | 2 |
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