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Global Regulatory Affairs Professional

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Kelly Scientific is looking for a pharmaceutical company localized in Switzerland a : GRA Professional (temporary position until the end of September 2015).

Your mission :
Execution of global and regional regulatory strategies for the approval of new products, switches and maintenance activities (variations and renewals), for a defined portfolio of products.

Your responsabilities ;
· Supports regional and local regulatory affairs colleagues for new registrations/accreditations, switches and life-cycle maintenance of defined products.
· Prepares or customizes registration/accreditation files, switch dossiers, renewal and variation dossiers/documents. Prepares specific regional Module 1 documents and official attestations. Provides files and information to countries and support local RA counterparts in the countries in responding to Health Authorities queries. Follows up registrations/accreditations and variations
· May manage global regulatory procedures with support from GRA Manager and/or GRA Category Lead
· May contribute to or represent GRA in Core Teams for assigned projects. May provide, with support from GRA Manager and/or GRA Category Lead, regulatory advice regarding new registrations and life cycle maintenance, and interacts with colleagues in other departments, other R&D functions and Regulatory Affairs functions to obtain required documentation and materials
· May support GRA Manager and/or GRA Category Lead in the evaluation of new opportunities (including due diligence as required) and product development requirements by doing necessary surveys and searches
· May contribute to special assigned activities within the team or represent GRA in cross-functional assignments i.e. SME teams, task force teams, etc
· May coach a regulatory colleague with the supervision of GRA Manager and/or GRA Category Lead

Your profile :
· Minimum MS, preferred Pharmacist or PhD
· 0- 4 years in Pharmaceutical Regulatory Affairs
· Fluent in English required

Please send your application at :

Region: Vaud
Vertragsart: Befristet
Kategorie: Strategie & Management;
Veröffentlicht am: 02.07.14
Beschäftigungsart: Vollzeit (100%)
Job Nummer: JO-1407-10531
Abteilung: Kelly Services, Inc. in Switzerland is a leader in providing innovative workforce solutions. Kelly offers a comprehensive array of custom-designed outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and permanent basis. Kelly provides employment to more than 200 people in over 40 branches and specialist department throughout Switzerland.

Kelly specializes in providing professional/technical workforce solutions, with local expertise. These solutions include Finance, Science, and Medical. Kelly has a rich history in developing our solutions to address the workforce challenges of these communities, with expert staff dedicated to providing integrity and technical competency to ensure high performance, and proven results from its specialty talent.Link megjelenítése" width="0" height="0" />
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