| Outsourcing and Consulting Services for Life Sciences
Regulatory Affairs Manager Switzerland
In France, Europe and internationally, ProductLife Group is the leading, proven and trusted PanEuropean specialist-outsourcing-services provider for the regulatory, safety and quality functions of the life sciences and cosmetics industries. See also: www.productlifegroup.com To support our dynamic growth we are looking for motivated colleagues, eager to learn who have the ambition and potential for growth in our dynamic and international organization Location: Basel (home office partially) Type of contract: permanent
Job Description : Under monitoring of the Head of Practice and Principal Practice, you will have the responsibility for allocated projects within the Regulatory Affairs function. In this this position your missions are: -Ensure the implementation of regulatory activities of the regulatory Platform / Hub. Regulatory activities include pre-registration activities, the new registration (sites and medicines), post licensing regulatory submissions, interaction with the health authorities on behalf of clients PLG. -Compile or supervise the compilation of regulatory files respecting national requirements. -Obtain approval from regulatory authorities. -Provides on-going regulatory advice to project teams to ensure regulatory concerns are planned and accounted for and the relevant data are generated to meet project objectives. -Provide regulatory support to clients and associates. -Liaising with external regulators as required. -Provide format and contents review of packaging texts, Summary of Product Characteristics and labelling. -Review tasks for support and to accompany Regulatory Affairs Associates. -Assist responsible for platform / Hub Senior Regulatory Affairs consultants before sales: -Provide technical support before sales -Ensure adequate technical description of the proposals and support sales for quotation evaluation -Ensure that invoicing is correctly set © PLG
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Auteur : HPA
Page 1 / 4 Dernière mise à jour : 9 Octobre 2015