Work as Regulatory Affairs Associate in Global Regulatory Affairs team at Novo Nordisk
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 Affairs Associate in Global Regulatory Affairs team
About the department :
Global Regulatory Affairs (GRA) in Bangalore consists of eight departments that work across our global processes and support both colleagues in Head Quarter Denmark (DK) as well as colleagues in our affiliates all over the world. As the area is growing, the total area will by midyear 2019 consist of approximately 120 dedicated employees. Regulatory Operations, Global Business Services (GBS) is an integral part of Regulatory Operations, Denmark (DK). The objective of this team is to ensure efficient and competitive Regulatory Operations to support Regulatory Affairs Headquarters (HQ) and Regulatory Affairs (RA) Affiliates. The team provides the services in Submission Management, Regulatory Information Management and operational graphic design.
The Position :
As Regulatory Affairs Associate, you will be responsible for Global regulatory publishing (electronic and paper) as per CTD/eCTD/NeeS/National format. Facilitates the integration and alignment of project plans and planning activities by providing regular reports on the status of the project including a final report.
Furthermore, you will also be responsible for support in publishing of standard file or extended standard files to submissions and ensure process implementation or improvements within Publishing Support GSC, as per the extended publishing support need..
• Graduation / Post Graduation or comparable degree or equivalent professional experience
• 0 to 1 year experience in Pharmaceutical Industry in Regulatory Affairs
• Experience in compilation of dossier in eCTD, NeeS & Standard format
• Experience in Document Management system
• Has analytical skills with the ability to focus on detail and still keep the overview
• Reaches agreements through flexibility
• Analyses and takes initiative to improve procedures that are not providing value to the business
• Ability to identify gaps and possible areas of improvement within team/department/area
• Think ahead and identify challenges, work independently, proactively and efficiently
• Being critical and challenging
Qualification : B.Sc, M.Sc, M.Pharm, B.Pharm
Location : Bangalore, Karnataka
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Global Regulatory Affairs
End Date : 6th May, 2020
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