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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