Require Regulatory Affairs Associate Analyst 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 Analyst

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 publishing the submission of Marketing Authorisation Application (MAA)/Life cycle Management application to European Health Authorities along with regulatory global publishing (electronic and paper) as per CTD/eCTD/NeeS/National format.

Additionally, you will also be responsible for supporting the STF/ESTF publication process across HQ, implementation of extended Publishing process along with maintenance and user support of regulatory systems and processes within area of responsibility.

Candidate Profile
• Post Graduate or comparable degree in Science, computer related feild or equivalent professional experience
• Above 5 years of experience in Pharmaceutical Industry in Regulatory Affairs
• At least 3 years of relevant experience in regulatory publishing
• Exposure to EU & US submissions is must
• Excellent Communication Skills
• Strong stakeholder management and ability to work with stakeholder across geographies
• Experience of compilation of dossier in eCTD, NeeS & Standard format
• Experience in Document Management system

Additional Information
Qualification : M.Sc
Location : Bangalore, Karnataka
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory Affairs
End Date : 25th January, 2020