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 Pre & Post Publishing Checks - RA Associate III
Job Desciption
As RA Associate III 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 checking the quality of documents (both Pre & Publishing publishing pahse). You will be responsible to check & identify show stopper elements which will potentially casue error while doing eCTD/electronic publishing. You will also perform quality check of dossier once published, to ensure no peotential error occured while publishing. As a secondary activity you will also support publishing activity for the compilation & 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 Adobe Acrobat, ISI Tool Box & eCTD software or any Regulatory dossier publishing software. We also expect you to have good understanding of solving validation error.
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.
Candidate Profile
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 2 years (preferred job experience in handling Document checks). 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.
Additional Information:
Experience: 2 years
Qualification: M.Sc, M.Pharm
Location: Bangalore
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Pharmacovigilance
Post Date: 3 Feb, 2015
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