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 Analyst for Regulatory Affairs department
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 Service Centre (GSC) is an integral part of Regulatory Operations DK. The objective of this team is to ensure efficient and competitive Regulatory Operations to support Regulatory Affairs HQ and RA Affiliates. The team provides the services in Submission Management, Regulatory Information Management and Operational Graphic Design.
The position
As Regulatory Affairs (RA) Analyst, you will be responsible for compiling and supporting the submission of renewal applications globally. You would also be responsible in submission planning with RA colleagues in different countries, compilation of National Table of Contents (TOCs) based on the country’s local requirements along with requesting for additional documentations from RA colleagues in headquarters, as per the local requirements, coordination of registration samples when samples are required with our publishing colleagues and quality check of the published registration dossiers.
Additionally, you will also be responsible in delivering high quality registration dossiers, which require a good understanding of Regulatory guidelines, Module 1 documentation, different registration file formats and the Regulatory dossier compilation process.
Candidate Profile
• Post graduate education in Science (e.g. Master of Pharmacy, Biotechnology, Medicinal Chemistry, Life sciences)
• 5-8 years in handling eCTD/NeeS/National format dossier & Table of content compilation for different markets (US/EU & rest of the World)
• Excellent communication and English proficiency
• Stakeholder Management
Additional Information
Qualification : M.Pharm, M.Sc
Location : Bangalore, Karnataka
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 27th December, 2019
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