Novo Nordisk require Associate Analyst in Regulatory Operation

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 : Associate Analyst - Regulatory Operation

The position
Your key responsibility will be Compilation and delivery of country specific files across IO for Renewals and Additional Manufacturing sites by preparing operational plan and check list of local requirements for each submission. Circulate the plans and requirements to RA in Affiliate for confirmation, TOC compilation according to compliance form or according to Site Transfer TOCs provided by RA CMC & Devices: search for documents in novoDOCS and populate TOC, Raise Publishing Online Form request according to submission size and publishing lead-times and QC of Published Output and Maintain the submission tracker.

Candidate Profile
• Graduate or Post Graduate in Science or comparable degree in computer related field or equivalent professional experience
• Around 5 years experience in Pharmaceutical Industry in Regulatory Affairs
• Experience in compilation of Registration / Re-registration dossier in National / eCTD / NeeS and Standard format
• Experience in Document Management system
• Speaks and writes English at a professional level
• Is service minded and customer oriented
• Demonstrates a high-quality mindset
• Structured and organized and ability to maintain the overview
• Ability to work in teams
• Ability to perform in peak periods, work under tight deadlines and under a high work load
• Focuses on targets and delivers results
• Act proactively
• Works independently
• Good Analytical Skills
• Easily adaptable to team environment
• Strong work ethics and integrity

Additional Information
Qualification : B.Sc, M.Sc
Location : Bangalore, Karnataka
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory Operation
End Date : 25th June, 2020