lowongan kerja PT Bifarma Adiluhung (Innogene Kalbiotech) Juni 2013

Innogene Kalbiotech Pte. Ltd. is a company that develops and commercializes innovative drugs and diagnostics. Innogene is a subsidiary of PT Kalbe Farma Tbk in Indonesia, today’s largestpublicly-listed pharmaceutical company in South East Asia. Our new line of innovative products requires excellent organizational skill, resourceful and independent talents to increase sales to the higher level. Therefore, we are looking for person to fill in the following position: Regulatory Affair Officer Jakarta Raya Responsibilities: Familiar with the registration of the new biological and biosmilar products in ASEAN countries Careful planning to achieve accurate and timely results Work precisely according to procedures, rules and regulations Recognise recurring issues and analyse their causes in order to reach a solution Manage and facilitate all registration related activities Complete forms and requests originating from government agencies Maintain contact with regulatory authorities and company headquarters Provide the Project teams with regulatory input in order to obtain timely regulatory approvals for the products as part of the product development planning Implement QA systems and generate SOPs Deal with quality related questions and complaints Update licensing and collect information on registration instructions and regulations Requirements: Degree in Pharmacy. Diploma holders in Pharmaceutical Sciences will be considered. Fluent in English and Mandarin, both spoken and written Meticulous, good organizational and communication skills. Positive work attitude. Adaptable, independent, works well under pressure. Willing to travel A competitive remuneration package will be offered to the successful candidate. Candidates who do not have any requirements as mentioned above are advised NOT to apply. Please submit your CV, recent photographs and credentials to: siti.musarofa@kalbe.co.id or search.talent@ymail.com