Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within Haemophilia care, growth hormone therapy and hormone replacement therapy. Headquartered in Denmark, Novo Nordisk employs approximately 33,300 employees in 75 countries, and markets its products in more than 190 countries Novo Nordisk’s B shares are listed on NASDAQ OMX Copenhagen (Novo-B).
Post: Regulatory Affairs Analyst
Job Description
As RA Analyst 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 & extending support for re-registration dossier in market outside US/EU. We expect you to have good working experience in compilation of Renewal dossier for ROW countries, understanding Regulatory guidelines, understanding of eCTD/NeeS format, Regulatory software & Regulatory dossier compilation process. We also expect you to have good understanding of solving error & trouble shooting compilation issues.
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.
Candidate Profile
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 for atleast 3-4 years (preferred job experience in handling eCTD/NeeS/National format dossier in US/EU/ROW market). 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.
Additional Information:
Experience: 3-4 Years
Qualification: M.Pharm, M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Regulatory Affairs
Location: Karnataka
Requisition ID 42793BR
Last date: 22nd Feb, 2017
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