Work as Regulatory Affairs Associate Analyst at Novo Nordisk | M.Sc, M.Pharm



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 Associate Analyst

Job Description
As RA Associate Analyst, you will be responsible for compiling and publishing the submission of Marketing Authorisation application (MAA)/Life cycle Management application to European Health Authorities. The key responsibilities are:
• Facilitation of submission planning meetings with RA colleagues from Product portfolio as well as Submission Management coordinator from RAHQ Denmark
• Compilation of dossier based on  TOCs  provided by RA HQ in eCTD format
• Publishing the dossier & perform post publishing activities
• Add navigation elements like hyperlinks, Bookmarks
• Perform validation of submission
• Upload submission in EMA Gateway

Candidate Profile
You have a post graduate education in science (e.g. Master of Pharmacy, Biotechnology, Medicinal Chemistry, Life sciences) and experience in working with Regulatory Affairs. You should have atleast 5 years of expierience and atleast 2 years of relevant expierience in handling eCTD/NeeS/National format dossier especially for EU countries. You should have strong IT system knowledge for Regulatory dossier publishing.   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 organised, service minded, positive, engaged and actively contribute to a good team spirit .

Additional Information
Experience : 2 years
Qualification : M.Sc, M.Pharm
Location : Karnataka - Bangalore
Industry Type : Pharma/ Healthcare
Functional Area :  Regulatory Affairs
End Date : 15th November, 2018


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