Regulatory Affairs
Bangalore
You will join the Regulatory Affairs Operations function consisting of 52 colleagues, divided in 4 (four) departments. The position is based in the department for re-registration & renewals of Novo Nordisk products. We have a wide range of stakeholders within development, QA, medical, marketing, product supply as well as Regulatory Affairs in our Head Quarters at Denmark & affiliates across the globe. Our main activities are to maintain the Regulatory licences for the approved product, keep a track on renewal & re-registration based on current laws and regulations regarding medicinal product for human use and to get the innovative product marketed worldwide for the benefit of patient.
The job
As RA Analyst III your primary focus is to make sure the department can support the development, registration and maintenance of our product worldwide.
Your task will be focused on compiling re-registration dossier for Gulf, Africa, Latin America, CIS Region & Asian Region countries.
You will follow product development projects from the early phases into maintenance, providing input and translating complex regulatory issues into valuable information to the products, to ensure the best regulatory strategy during the life cycle management.
Our organisation is dynamic, with change management being an integral part of our everyday life.
In addition there is a constant focus on optimizing our working processes, and you will be involved in cross functional projects and improvement initiatives within and outside the RA organisation, as well as collaboration with development, medical, marketing, product supply and quality assurance departments as well as Regulatory professionals from Affiliates across the globe.
Qualifications
We expect you to have a Post graduate education within the healthcare area (e.g. Master of Pharmacy, Biotechnology, Medicinal Chemistry, Life sciences) and experience in working with regulatory affairs (preferred job experience in handling Africa Region, CIS Region, LATAM, BRIC markets). As a person you thrive in busy environments and you bring a can-do spirit and a healthy common sense and a sense of humour to your work – even when the pressure is on. You’re a strong team player, but you also enjoy working independently. Furthermore you are well organised and a good planner. You are a skilled communicator, who is able to collaborate with a lot of stakeholders and comfortable using your fluent written and spoken English on a daily basis. Finally, you have a flair for IT systems and experience with MS Office.
Regulatory Affairs is an organisation with many international employees. We expect you to work in multicultural company.
At Novo Nordisk, we have been changing diabetessince 1923. If you are ready to strengthen our position as an innovative pioneer and respected industry leader, we encourage you to join us to make the most of your talent.
Contact
For further information, please contact Surajit Roy on +91 80 39988629
Deadline 12 September 2014
Read More
Bangalore
You will join the Regulatory Affairs Operations function consisting of 52 colleagues, divided in 4 (four) departments. The position is based in the department for re-registration & renewals of Novo Nordisk products. We have a wide range of stakeholders within development, QA, medical, marketing, product supply as well as Regulatory Affairs in our Head Quarters at Denmark & affiliates across the globe. Our main activities are to maintain the Regulatory licences for the approved product, keep a track on renewal & re-registration based on current laws and regulations regarding medicinal product for human use and to get the innovative product marketed worldwide for the benefit of patient.
The job
As RA Analyst III your primary focus is to make sure the department can support the development, registration and maintenance of our product worldwide.
Your task will be focused on compiling re-registration dossier for Gulf, Africa, Latin America, CIS Region & Asian Region countries.
You will follow product development projects from the early phases into maintenance, providing input and translating complex regulatory issues into valuable information to the products, to ensure the best regulatory strategy during the life cycle management.
Our organisation is dynamic, with change management being an integral part of our everyday life.
In addition there is a constant focus on optimizing our working processes, and you will be involved in cross functional projects and improvement initiatives within and outside the RA organisation, as well as collaboration with development, medical, marketing, product supply and quality assurance departments as well as Regulatory professionals from Affiliates across the globe.
Qualifications
We expect you to have a Post graduate education within the healthcare area (e.g. Master of Pharmacy, Biotechnology, Medicinal Chemistry, Life sciences) and experience in working with regulatory affairs (preferred job experience in handling Africa Region, CIS Region, LATAM, BRIC markets). As a person you thrive in busy environments and you bring a can-do spirit and a healthy common sense and a sense of humour to your work – even when the pressure is on. You’re a strong team player, but you also enjoy working independently. Furthermore you are well organised and a good planner. You are a skilled communicator, who is able to collaborate with a lot of stakeholders and comfortable using your fluent written and spoken English on a daily basis. Finally, you have a flair for IT systems and experience with MS Office.
Regulatory Affairs is an organisation with many international employees. We expect you to work in multicultural company.
At Novo Nordisk, we have been changing diabetessince 1923. If you are ready to strengthen our position as an innovative pioneer and respected industry leader, we encourage you to join us to make the most of your talent.
Contact
For further information, please contact Surajit Roy on +91 80 39988629
Deadline 12 September 2014
Read More
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