Saturday, November 30, 2019

NOVO NORDISK Regulatory Affairs Analyst


NOVO NORDISK Regulatory Affairs Analyst 


Category:  Regulatory

Location:  Bangalore, Karnataka, IN

Are you service minded and have a can-do attitude with continuous improvement as one of your career objectives? Join Global Regulatory Affairs (RA) Bangalore at Novo Nordisk and get a life-changing career.

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.

Qualifications

You will need to have the below knowledge and experience.

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

Working at Novo Nordisk

At Novo Nordisk, we create value by putting patients first. Every ten seconds two people are diagnosed with diabetes, & more than 371 million people worldwide need us. Working here is not just a way to make a living, but a way to make a difference.

Contact

For further information, please contact Ganesh Shetty at gsy@novonordisk.com.

Deadline

27 December 2019

TO APPLY NOW CLICK HERE



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