Job in Regulatory Publishing as RA Associate in Novo Nordisk | M.Sc, M.Pharm
Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within Haemophilia care, growth hormone therapy and hormone replacement therapy. Headquartered in Denmark, Novo Nordisk employs approximately 33,300 employees in 75 countries, and markets its products in more than 190 countries Novo Nordisk’s B shares are listed on NASDAQ OMX Copenhagen (Novo-B).
Post: Regulatory Publishing - RA Associate
As RA Associate 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.
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 1 year (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
Experience: 1 Year
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Regulatory Affairs
Last date: 30th Jan., 2017
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