Regulatory & Submission Publisher

Sector: Farmaceutica
Niveau:
Plaats: Oss
Solliciteer

Beschrijving

In the area of Den Bosch Organisation

The 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 description

One 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 requirements

For 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
Offer

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.

LabResource is het grootste laboratorium recruitment bureau in Nederland, gespecialiseerd in uitzenden, detacheren en werving & selectie binnen: Quality Assurance / kwaliteitszorg, research en development, product ontwikkeling, laboratoriumco?rdinatie en management, procesvalidatie en optimalisatie.

Vacatures waar wij voor werven zijn onder andere: laborant, analist, quality Assurance officer, laboratoria manager, R & D medewerker, applicatie specialist, organisch/ synthetisch technician, science / wetenschappelijk medewerker, technicians. Vakgebieden zijn onder andere: biochemie, life science, moleculair biologie, analytische chemie, petro chemie, microbiologie, biotechnologisch, scheikunde, organische chemie, synthese, voedingsmiddelen, farmacie, petrochemie, milieu chemie, scientific sales, geur en smaakstoffen, klinisch/medische chemie, medical devices, food & nutrician.

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