Last Date: 15th April, 2019
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).
1.Name of the post- Senior Analyst – Regulatory Affairs
The position As Regulatory Affairs (RA) Senior Analyst, you will be responsible for compiling and publishing the submission of Marketing Authorisation Application (MAA)/life cycle management application to European Health Authorities. Your key responsibilities are facilitation of submission planning meetings with RA colleagues from Product portfolio as well as submission management coordinator from Regulatory Affairs at Headquarters (RAHQ) Denmark, compilation of dossier based on Table of Contents (TOCs) provided by RA HQ and Affiliates in Electronic Common Technical Document (eCTD) format, publishing the dossier & perform post publishing activities, add navigation elements like hyperlinks, bookmarks, perform validation of submission and upload submission in European Medicines Agency (EMA) Gateway.
You will be delivering high quality registration dossiers, which require a good understanding of regulatory guidelines, administrative, chemistry, manufacturing and control (CMC), non-clinical & clinical documentation, different registration file formats (centralised procedure, mutual recognition procedure, decentralised procedure & national procedure for European Union (EU)) and the regulatory dossier publishing process. Hands on experience in publishing tools like Lorenz Docubridge, Liquent Insight, ISI Publishing, ISI Tool Box, Adobe Acrobat, etc. Hands on experience in validation tool like EURS, Lorenz, etc. Experience in xml editing & Document Management system is preferable. Exposure to e-submission gateways are mandatory.
The job involves close collaboration with global regulatory teams in Denmark, as well as Novo Nordisk affiliates across the EU to ensure timely submissions. Excellent communication and English proficiency is a must, especially with the global perspective of the role. Stakeholder satisfaction is one of the departmental and individual goals, so service mindedness towards our stakeholders within Novo Nordisk is a key priority. Our organisation is dynamic, with change management being an essential part of our everyday life. In addition, there is a constant focus on optimising our working processes, and you will be involved in cross functional improvement activities.
You should hold a Post Graduate or comparable degree in Science (e.g. Master of Pharmacy, Biotechnology, Medicinal Chemistry, Life Sciences, etc.) or equivalent professional experience and have at least two years of experience in Pharmaceutical Industry in Regulatory Affairs. Experience of compilation of dossier in eCTD, NeeS & Standard format and document Management system is preferred. Intermediate knowledge in MS-Office is preferred. Because of the Global nature of work, we need you to have basic personal skills such as good communication skills, stakeholder management, detail oriented, readiness to change, service minded and customer oriented. We expect you to demonstrate a high-quality mindset and accountable towards your task. You should have the ability to work well as an individual and in teams.
Qualification: M.Pharm, M.Sc
Location: Karnataka – Bangalore
Industry Type: Pharma / Healthcare / Clinical research
Functional Area: Regulatory Affairs
End Date: 15th April, 2019
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