Regulatory Affairs Coordinator
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Hørsholm
Do you meet challenges with a smile? We are expanding with a new Regulatory Affairs Coordinator for our regulatory CMC activities.
The position
You will take up the position as Regulatory Affairs Coordinator and join the Regulatory CMC, Tablets and Next Generation team which is part of Global Regulatory Affairs (GRA). We are based at the ALK headquarter in Hørsholm and so will you be.
As Regulatory Affairs Coordinator, you will be given a range of responsibilities within regulatory affairs, both coordinative and operational tasks. The tasks will be solved by use of interdisciplinary collaboration with both internal and external stakeholders. You will work closely together with team colleagues and share experience and learnings with other Regulatory Affairs Coordinators working in GRA.
In this role you will:
What you bring
We expect you to have a technical education or similar relevant education preferably combined with experience from the pharmaceutical industry.
It is an advantage if you have experience in e-submissions, document management systems and from working in a global regulatory affairs department.
As there are several parallel activities and deadlines to manage, your good planning skills and ability to keep perspective in times of increased activity, are key to your success. In addition, we expect you to bring:
Become a part of ALK
At ALK, we provide you a uniquely dynamic and pleasant work environment, with inspiring and challenging assignments. The result of your efforts will be significant throughout the organisation, and you will be able to actively influence and challenge the status quo. The flat structures in ALK attract independent individuals who like to feel the progress of the business and enjoy being close to the decision-making process.
The working environment is informal and dynamic, and we support each other to become a success. All together in Global Regulatory Affairs we are 60 people.
Contact
If you want to know more about the position, you are welcome to contact Dorte Friis Christensen on telephone +45 2145 3919.
Apply
Please submit your application and CV as soon as possible, and no later than 27 November 2022. We will screen applicants and call for interviews on an ongoing basis, so don’t wait to apply!
We look forward to hearing from you.
The position
You will take up the position as Regulatory Affairs Coordinator and join the Regulatory CMC, Tablets and Next Generation team which is part of Global Regulatory Affairs (GRA). We are based at the ALK headquarter in Hørsholm and so will you be.
As Regulatory Affairs Coordinator, you will be given a range of responsibilities within regulatory affairs, both coordinative and operational tasks. The tasks will be solved by use of interdisciplinary collaboration with both internal and external stakeholders. You will work closely together with team colleagues and share experience and learnings with other Regulatory Affairs Coordinators working in GRA.
In this role you will:
- Coordinate regulatory e-submission activities for strategic tablet products registered globally
- Be contact point for eCTD compilation provider, consultants, and affiliates in relation to submissions
- Take responsibility for selected pre- and post-submission activities
- Write and update quality procedures and instructions in our quality management system
What you bring
We expect you to have a technical education or similar relevant education preferably combined with experience from the pharmaceutical industry.
It is an advantage if you have experience in e-submissions, document management systems and from working in a global regulatory affairs department.
As there are several parallel activities and deadlines to manage, your good planning skills and ability to keep perspective in times of increased activity, are key to your success. In addition, we expect you to bring:
- Good communication skills (written and spoken)
- Good English skills (written and spoken)
- Well-structured in mindset and an eagerness to complete the tasks according to deadline
- An eye for details
- Service minded approach
Become a part of ALK
At ALK, we provide you a uniquely dynamic and pleasant work environment, with inspiring and challenging assignments. The result of your efforts will be significant throughout the organisation, and you will be able to actively influence and challenge the status quo. The flat structures in ALK attract independent individuals who like to feel the progress of the business and enjoy being close to the decision-making process.
The working environment is informal and dynamic, and we support each other to become a success. All together in Global Regulatory Affairs we are 60 people.
Contact
If you want to know more about the position, you are welcome to contact Dorte Friis Christensen on telephone +45 2145 3919.
Apply
Please submit your application and CV as soon as possible, and no later than 27 November 2022. We will screen applicants and call for interviews on an ongoing basis, so don’t wait to apply!
We look forward to hearing from you.
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 12.11.2019, 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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