job details posted 09. March 2018 location zürich, zurich sector Life Sciences job type contract reference number 10793 contact filipa lessa, basel professionals health care & life sciences phone 058 201 55 50 apply now email job description Our client, a research based pharmaceutical company leader worldwide, we're actively looking for a : Junior Regulatory Affairs Manager (50%) Location: Zurich Contract Length: until Dec 2018 Startdate : to be discussed Position purpose: Processing of new licenses, maintenance and care of licenses and maintenance of the marketability of drugs and medicinal products in Switzerland and any other associated /relevant activities. Primary Responsibility: Determine the appropriate licensing strategy in accordance with HRA and/or RAM Coordinate collaboration with WSR Obtain and assess the marketing authorization documentation, compile and customize it to meet the local requirements of Swissmedic Ensure the update of all relevant databases Ensure that the applications are submitted as quickly as possible with the best possible labeling Ensure that new marketing authorisations (MAs), line extensions (LEs) are processed in accordance with local laws and guidelines as well as local SOPs Carry out file processing on schedule, if necessary speed up the process by making formal / informal contacts with Swissmedic Participate in discussions / negotiations with the authority and provide appropriate organization of meetings with the authority Maintenance of marketing authorisations (e.g. core data sheet updates, variations, renewals, PSURs, MR-conditions Create and maintain the Local Product Document (LPD), Local Language document (LLD; Fachinformation), the local Patient Information Leaflet (PIL; Patienteninformation) and the abbreviated LLD (FI-kurz; Fachinformation kurz) as well as the packaging elements as appropriate in accordance with the local procedures and Swissmedic guidelines Representation of the company / division with internal and external customers Collaborate with HUB colleagues to ensure HUB support is appropriately aligned with Swissmedic requirements Make sure that local laws and guidelines as well as local SOPs are always met Provide support for all audits under Medical Director / Platform Head (Regulatory/Safety) Accountability, including audit corrective and preventive action plans (CAPAs). Technical Skills Requirements: Extensive knowledge of the current Swiss regulatory and drug laws environment, knowledge about other legal environments (EU, US, etc.) is of advantage Very good knowledge of German and English, good knowledge of French, knowledge of Italian is of advantage Solid knowledge of pharmaceutical analytics technology, pharmacology, toxicology and medicine Qualifications: Academic degree in natural sciences (pharmacy, chemistry, biochemistry, biology or medicine) Min. 2 years work experiences in Regulatory Affairs Knowledge of or experience in project management techniques is of advantage Clear verbal and written communication Strong skills in productivity, organizational and time management in order to meet strict regulatory compliance goals High quality standards Ability to work independently as well as part of a team We are looking forward to receiving within your application: your CV in English latest Work Certificates your Motivation Letter ID/passport copy Copy of Work Permit Apply now to be considered! For more information and your application, please contact: Filipa Lessa, Recruiter Lifesciences, Randstad Professionals, filipa.lessa@randstad.ch, +41 58 201 55 50 share: Facebook LinkedIn Twitter Xing