Regulatory & Submission Publisher
| Sector: | Farmaceutica |
|---|---|
| Niveau: | |
| Plaats: | Oss |
Beschrijving
In the area of Den Bosch OrganisationThe organisation is a world leading international pharmaceutical company. You will be working in an international environment with a professional atmosphere.
The department Global Regulatory Operations is responsible for assembly, delivery and archiving of registration submissions. The department is located in the US and in Europe. In Europe there are two locations.
Job descriptionOne of the tasks within the department GRO (Global Regulatory Operations) is assembly, delivery and archiving of registration submissions for the whole portfolio of this pharmaceutical company. GRO is located in the US and in Europe (two locations).
Currently we are looking for a temporary, project related, Registration and Submission Publisher.
The project entails the creation of manufacturer name change variations for several API's in 30 products, globally registered. This means submissions have to be created in all formats (eCTD, NeES, paper) and for all procedures (Central, Mutual, National), possibly also in grouping or work sharing.
Main tasks:
- making Name Change Variations for worldwide registrated products
- coordinating and prioritizing your own work
- plan and built submissions
- international contacts
We only ask candidates and clinical professionals with a minimum of 2 years registration and submission experience within a pharmaceutical environment to apply for this position.
This position is for the a temporary period: starting between September 1st and October 1st and ending at the end of February 2014.
Job requirementsFor the vacancy of Regulatory & Submission Publisher we are looking for clinical or RA professionals with the following background and experience:
- education in a relevant discipline (Chemistry, Pharmacy, Life Sciences)
- minimal 2 years within RA / registrations / submissions is mandatory
- work experience within a pharmaceutical environment is mandatory
- Knowledge about publishing systems (preferably Liquent (Parexel))
- You are familiar with relevant, worldwide registration and submission requirements
- Very good command of English, both spoken and written
- Command of the Dutch language is an advantage
- Teamplayer with accurate and organisational skills, capable of dealing with high time pressure and deadlines
Period: until end of March 2014
Salary indication: Euro 3700 - Euro 4500 gross per month
Fultime (40 hrs/week)
Region of Den Bosch
Challenging position for a regulatory affairs professional within one of the biggest pharmaceutical companies.
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