Post : Regulatory Affairs Analyst
Job Description
As Regulatory Affairs (RA) Analyst, you will be responsible for compiling and supporting the submission of renewal applications globally. The key responsibilities will be submission planning with RA colleagues in different countries, compilation of National Table of Contents (TOCs) based on the countries’ local requirements, request additional documentations from RA colleagues in Head Quarter (HQ), as per the local requirements and do the coordination of registration samples when samples are required.
As Regulatory Affairs (RA) Analyst, you will be responsible for compiling and supporting the submission of renewal applications globally. The key responsibilities will be submission planning with RA colleagues in different countries, compilation of National Table of Contents (TOCs) based on the countries’ local requirements, request additional documentations from RA colleagues in Head Quarter (HQ), as per the local requirements and do the coordination of registration samples when samples are required.
The job involves close collaboration with Global Regulatory Teams in Denmark and Bangalore, as well as Novo Nordisk affiliates across the globe to ensure timely submissions. Excellent communication and English proficiency is a must, especially with the global perspective of the role. Stakeholder satisfaction is one of the departmental and individual goals, so service mindedness towards our stakeholders within Novo Nordisk is a key priority.
You will be 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)
• Experience in working with Regulatory Affairs for 5-8 years in handling eCTD/NeeS/National format dossier & Table of content compilation for different markets (US/EU & Rest of the World)
• As a person, you thrive in a busy environment and you bring a can-do attitude. You’re a strong team player, but you also enjoy working independently
• You are a skilled communicator, who can collaborate with a lot of stakeholders and comfortable using your excellent written and spoken English proficiency on a daily basis
• Furthermore, you have flair for IT systems and experience with MS Office
• We expect you to be a good planner, well organised, service minded, positive, engaged and actively contribute to a good team spirit
• Post graduate education in Science (e.g. Master of Pharmacy, Biotechnology, Medicinal Chemistry, Life Sciences)
• Experience in working with Regulatory Affairs for 5-8 years in handling eCTD/NeeS/National format dossier & Table of content compilation for different markets (US/EU & Rest of the World)
• As a person, you thrive in a busy environment and you bring a can-do attitude. You’re a strong team player, but you also enjoy working independently
• You are a skilled communicator, who can collaborate with a lot of stakeholders and comfortable using your excellent written and spoken English proficiency on a daily basis
• Furthermore, you have flair for IT systems and experience with MS Office
• We expect you to be a good planner, well organised, service minded, positive, engaged and actively contribute to a good team spirit
Additional Information
Qualification : M.Pharm, M.Sc
Location : Karnataka - Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 10th February, 2019
Qualification : M.Pharm, M.Sc
Location : Karnataka - Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 10th February, 2019
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