Regulatory Affairs Professional
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Hørsholm
For our injectable products registered globally we are seeking a regulatory colleague to manage regulatory CMC activities. You will join the Regulatory CMC, Injectable, Devices and Drops team which is part of Global Regulatory Affairs, and you will be based at our Head Office in Hørsholm. The working environment is informal and flexible, and sharing of learnings within the team is very important for us.
Your responsibilities will depend on your experience. Your daily task will cover preparation of regulatory CMC documentation and handling of the submissions to authorities. As there are several parallel activities and deadlines to manage your good planning skills will come into play.
In this role you will:
Your qualifications
You bring a Master of Science, e.g., in pharmacy, engineering or other relevant discipline along
working experience with regulatory CMC submissions , preferably in global scale an advantage. You thrive in scientific discussions with the goal of clarifying needs and identifying solutions, and you enjoy preparing clear and logically organised written material on complex scientific matters.
Moreover, we expect:
We offer
In Global Regulatory Affairs, we provide an attractive working environment for Regulatory Affairs Professionals looking for both personal and professional development. ALK is a global pharmaceutical company in progress offering unique job opportunities.
ALK provides a dynamic and pleasant work environment, complete with inspiring and challenging assignments. You will be part of an engaged team who values skill, teamwork and knowledge creation.
We consider our pioneering spirit coupled with our trustworthiness our winning formula. ALK is a health focused organization and our offices offer a green view of the DTU Science Park in Hørsholm.
Application deadline
Responders will be evaluated on an ongoing basis so don´t hesitate to apply for this position.
The application process will close end February 2023.
Contact
Visit our website www.alk.dk to learn more about our company. Interested in further information about the position, please contact Director, Lone Rønnemoes on telephone +45 25664085.
Your responsibilities will depend on your experience. Your daily task will cover preparation of regulatory CMC documentation and handling of the submissions to authorities. As there are several parallel activities and deadlines to manage your good planning skills will come into play.
In this role you will:
- Be responsible for scientific/technical writing and maintaining regulatory CMC (Chemistry, Manufacture and Control) documentation for initial and life cycle submissions for strategic product(s)
- Be responsible for having an overview of submitted and approved CMC documentation globally
- Have cross-functional and external cooperation related to product life cycle activities
- Communicate, coordinate, negotiate and align regulatory strategies as representative for regulatory CMC in regulatory working groups and cross-functional project teams as relevant
- Take on regulatory responsibility for compiling the CMC part of global applications and running life cycle submissions
- Establish the right strategy for CMC documentation and submission
- Evaluate regulatory impact for CMC changes
- Provide regulatory guidance for various cross-functional areas
- Monitor global regulatory requirements and conduct regulatory impact assessment related to CMC
Your qualifications
You bring a Master of Science, e.g., in pharmacy, engineering or other relevant discipline along
working experience with regulatory CMC submissions , preferably in global scale an advantage. You thrive in scientific discussions with the goal of clarifying needs and identifying solutions, and you enjoy preparing clear and logically organised written material on complex scientific matters.
Moreover, we expect:
- Basic knowledge of pharmaceutical industry and GMP
- Openness towards other departments and external stakeholders as well as a great sense of humour
- Good English skills, both in writing and orally
- Excellent communication skills, both in writing and orally
- Taking on responsibility for having the job done and being well structured
- Result oriented and able to keep the perspective in times of increased activity
We offer
In Global Regulatory Affairs, we provide an attractive working environment for Regulatory Affairs Professionals looking for both personal and professional development. ALK is a global pharmaceutical company in progress offering unique job opportunities.
ALK provides a dynamic and pleasant work environment, complete with inspiring and challenging assignments. You will be part of an engaged team who values skill, teamwork and knowledge creation.
We consider our pioneering spirit coupled with our trustworthiness our winning formula. ALK is a health focused organization and our offices offer a green view of the DTU Science Park in Hørsholm.
Application deadline
Responders will be evaluated on an ongoing basis so don´t hesitate to apply for this position.
The application process will close end February 2023.
Contact
Visit our website www.alk.dk to learn more about our company. Interested in further information about the position, please contact Director, Lone Rønnemoes on telephone +45 25664085.
Information og data
Denne ledige stilling har jobtypen "Laborant", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Hørsholm.
Jobbet er oprettet på vores service den 5.7.2019, 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.
- Laborant
- Hørsholm
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