Job Description
As RA Senior Associate, you will be responsible for compiling and supporting the submission of manufacturing sites globally. The key responsibilities are: facilitation of submission planning meetings 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 HQ, as per the local requirements, coordination of registration samples when samples are required, quality Check of the registration dossiers, follow up with RA Affiliates on final submission to Health Authority You will be delivering high quality registration dossiers, which require a good understanding of Regulatory guidelines, Regulatory CMC documentation, different registration file formats and the Regulatory dossier compilation process.
As RA Senior Associate, you will be responsible for compiling and supporting the submission of manufacturing sites globally. The key responsibilities are: facilitation of submission planning meetings 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 HQ, as per the local requirements, coordination of registration samples when samples are required, quality Check of the registration dossiers, follow up with RA Affiliates on final submission to Health Authority You will be delivering high quality registration dossiers, which require a good understanding of Regulatory guidelines, Regulatory CMC documentation, different registration file formats and the Regulatory dossier compilation process.
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.
Candidate Profile
• We expect you to hold a post graduate education in science (e.g. Master of Pharmacy, Biotechnology, Medicinal Chemistry, Life sciences) and experience in working with Regulatory Affairs for 2-3 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 is able to 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 organized, service minded, positive, engaged and actively contribute to a good team spirit.
• We expect you to hold a post graduate education in science (e.g. Master of Pharmacy, Biotechnology, Medicinal Chemistry, Life sciences) and experience in working with Regulatory Affairs for 2-3 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 is able to 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 organized, service minded, positive, engaged and actively contribute to a good team spirit.
Additional Information
Experience : 2-3 years
Qualification : M.Pharm, M.Sc
Location : Bangalore
Requisition ID : 57771BR
Industry Type : Pharma
Functional Area : Regulatory
End Date : 26th August 2018
Experience : 2-3 years
Qualification : M.Pharm, M.Sc
Location : Bangalore
Requisition ID : 57771BR
Industry Type : Pharma
Functional Area : Regulatory
End Date : 26th August 2018
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