Regulatory Publishing - RA Analyst I Novonordisk, Bangalore|| HD 2 ift.tt/Yvsd4D Regulatory Publishing - RA Analyst I Novonordisk, Bangalore Talented Pharma Regulatory Professionals with potential to grow! Are you a Regulatory Affairs Publishing professional? Join Novo Nordisk Service Centre India Pvt. Ltd. to have a life changing career!About the department You will join the Regulatory Affairs Operations function consisting of 52 colleagues, divided in 4 (four) departments. The position is based in the department for Regulatory Publishing support. We have a wide range of stakeholders within development, QA, Clinical operations, Non-clinical operations, Medical, Marketing, product supply as well as Regulatory Affairs in our Head Quarters at Denmark & Affiliates across the globe. Our main activities are to provide Regulatory publishing support for submitting dossier in eCTD/NeeS/National/Health Authority Mandated format using software. This will ensure Registration of New Drug/maintain the Regulatory licences for the approved product, based on current laws and regulations regarding medicinal product for human use and to get the innovative product marketed worldwide for the benefit of patient.The job As RA Analyst I your primary focus is to make sure the department can support the development, registration and maintenance of our product worldwide. Your task will be focused on compiling & extending support for New registration dossier in EU/US in eCTD format. Responsible of compiling registration dossier in SwissMedic, Saudi FDA, Australia in eCTD format, Dossier compilation in ASEAN CTD format for ASEAN region, Dossier compilation in National format for Brazil, Mexico, Argentina, Jordan, Russia, Turkey, etc. For other countries in NeeS format . Health Authority mandated format. We expect you to have good working experience with eCTD software or any Regulatory dossier publishing software. We also expect you to have good understanding of solving validation error & trouble shooting publishing issues. Our organisation is dynamic, with change management being an integral part of our everyday life. In addition there is a constant focus on optimizing our working processes, and you will be involved in cross functional projects and improvement initiatives within and outside the RA organisation, as well as collaboration with development, medical, marketing, product supply and quality assurance departments as well as Regulatory professionals from Affiliates across the globe.Qualifications We expect you to have a Post graduate education within the healthcare area (e.g. Master of Pharmacy, Biotechnology, Medicinal Chemistry, Life sciences) and experience in working with regulatory affairs for atleast 4 years (preferred job experience in handling eCTD/NeeS/National format dossier using software). As a person you thrive in busy environments and you bring a can-do spirit and a healthy common sense and a sense of humour to your work – even when the pressure is on. You’re a strong team player, but you also enjoy working independently. Furthermore you are well organised and a good planner. You are a skilled communicator, who is able to collaborate with a lot of stakeholders and comfortable using your fluent written and spoken English on a daily basis. Finally, you have a flair for IT systems and experience with MS Office. At Novo Nordisk, we have been changing diabetes since 1923. If you are ready to strengthen our position as an innovative pioneer and respected industry leader, we encourage you to join us to make the most of your talent. At Novo Nordisk, we use our skills, dedication and ambition to help people with diabetes. We offer the chance to be part of a truly global work place, where passion and engagement are met with opportunities for professional and personal development.Contact For further information, please contact Surajit Roy on +91 80 39988629Deadline 10 October 2014 APPLY HERE
Posted on: Sun, 28 Sep 2014 03:54:23 +0000
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