Regulatory Affairs Scientist - CMC regio Oss

prijs
n.v.t.
datum plaatsing
02-07-13
adverteerder
LabResource
type
aangeboden
adverteert sinds
02-07-2013
plaatsnaam
Amsterdam
telefoon
020 - 406 97 50
gezien
22 x
snelcode info
2556092

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Omschrijving

Based in Oss
Organisation
The organisation is a world leading international pharmaceutical company. You will be working in an international environment with a professional atmosphere. The global CMC (Chemistry Manufacturing & Controls) Regulatory Affairs department is responsible for all activities needed to maintain existing product registrations worldwide . They also obtain new registrations of the local headquarters in Oss, in particular with respect to chemical and pharmaceutical aspects of the submissions.
Job description
As a Regulatory Affairs Scientist CMC you will work within the global CMC RA department, and you will work on change-control activities and documentation related to variations and registration renewals. Your main tasks will consist of the following: Defines and executes the registration strategy for submission of the API manufacturer name changes worldwide; Preparation of CMC documentation for international submissions in accordance with local dossier requirements; Taking part in the review and release of CMC documents in accordance with the applicable procedures; Supervision of the compilation of CMC dossiers; Leads or participates in discussions with local Merck Registration Managers and with the Health Authorities worldwide with respect to planned or submitted changes. Taking the initiative for and coordination of additional studies which are performed by the chemical/pharmaceutical disciplines; Maintains planning and tracking systems Supports new and existing CMC systems (RCAM, ORION, QSIS) and assures compliance with those systems We only ask candidates and clinical professionals with a minimum of 1-2 years registrations experience in a pharmaceutical environment to apply for this position.
Job requirements
For the vacancy of regulatory affairs scientist we are looking for clinical professionals with the following background and experience: minimal MSc education in a relevant discipline (Chemistry, Pharmacy, Life Sciences) minimal 1-2 years within registrations in CMC or in a GMP environment is mandatory You are familiar with relevant, worldwide registration requirements Good command of English, both spoken and written Command of the Dutch language is an advantage Teamplayer with well developed social and organisational skills.
Offer
Dienstverband: 1-2 jaar Salarisindicatie: Van Euro 4000 tot Euro 5500 bruto per maand Werktijden: 32-40 uur/week Regio: Oss
Challenging position for a regulatory affairs professional within Chemistry Manufacturing & Controls. 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
Interesse
Interesse, klik hier om direct te solliciteren. Ook kun je telefonisch contact opnemen met LabResource via T.: 024 - 79 99 920 of een CV per e-mail toesturen naar .



Opties:
- Functiegroep: onderwijs/onderzoek

Adverteerder: LabResource
Tel nr: (+31) 020 - 406 97 50
Website: http://link.advertentieplanet.nl/ko/0509407

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