Regulatory Operations Specialist EAME

BaselTemporaryChemistry, Pharma, Biotech2019-03-05Bachelor / University of Applied Sciences
For a leading biotechnology company in the global agribusiness market in Basel we are looking for a Regulatory Operations Specialist EAME - temporary employment for minimum 1 year with option for prolongation. •The Regulatory Operations Specialist EAME functions as liaison for collecting and managing requirements as well as business change requests and cooperates on behalf of the EAME Regulatory Process & Submission team and/or the EAME Regulatory Knowledge Management & Compliance Lead for an assigned area with respective global business or IT functions.

Regulatory Operations Specialist EAME

Your challenges

•Supports data management - provision, transfer, maintenance and quality - in regional Planning & Tracking as well as Document Management tools for the regional regulatory team and an assigned group of EAME territories & countries e.g.
•Upload to and maintenance of regulatory documents and information in PLANetc, Trackwise (Planning & Tracking Tool), SmartDoc (Document Management Tool) and PlantOS (Dossier Building & Publishing Tool)
•Provide expert and timely support in maintenance of up to date information in PLANetc, Trackwise (Planning & Tracking Tool) and SmartDoc (Document Management Tool) to ensure accurate and up-to-date records of EAME product registrations
•Supports & engages with regional, global and external IT functions on further development and continuous improvement of assigned tools and systems
•Collaborates & trains the assigned key contacts/superusers and the user community in order to improve quality and understanding of standards
•Supports the respective regulatory compliance activities driven from within the EAME Regulatory Knowledge Management & Compliance team
•Supports regional EAME Regulatory business management and analytics by providing reporting that facilitates regional KPI tracking e.g. ex PLANetc, Trackwise or other identified internal or external sources.

Your skills

•BA/BS or higher in Scientific, IT or Business discipline
•Scientific background in one of the key disciplines relevant for Crop Protection Regulatory would be beneficial e.g. in Chemistry or Biology
•2-5 years working experience in relevant fields
•Experience in an information management environment
•Good general understanding of business processes, data management procedures and IT systems and how this is managed within a regulated environment
•Highly competent in MS Office applications, DMS (Document Management Systems) like SmartDoc as well as planning & tracking tools e.g. Trackwise and ability in general to develop good understanding of purpose & data structure of tools quickly
•Good spoken and written English

Your horizons

•We offer an attractive package with competitive salary
•Professional and personal development
•Work life balance
•A dynamic and pleasant work location
•Temporary employment for minimum 1 year with option for prolongation

Your contact

Lisa Bianculli, Recruitment Consultant, looks forward to answer your questions by phone +41 58 233 2102 or eMail.

You can apply directly online, or by eMail. Please mention reference in your application