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.
Post : Regulatory Associate
This role requires someone to secure regulatory approvals of New Products, Clinical Trials, Medical Device &Variation submission for existing products to maintain the existing license in due time, for Novo Nordisk products in business areas. As a RA Associate you will be responsible to :
• Prepare and compile required documents for New Drugs, Clinical trial application, post approval variations towards HA as per agreed timelines with Medical, Commercial and CDC (Centres for Disease Control and Prevention) Trial managers.
• Perform QC (Quality Control) of HA (Health Authority) submission dossier prior to the submission.
• Proactively identify the potential queries from HA and share with relevant Medical, Commercial, CDC Trial managers and HQ RA CTA (Clinical Trial Applications) management team
• Complete HA submission as per agreed timelines
• Actively manage notification of the study status, renewal of the import licenses, annual updates of the study, protocol amendment, addition of the sites and other relevant correspondences required for the conduct of the clinical trial.
• Secure regulatory approvals of clinical trials, new products & Medical device as per agreed timelines, for Novo Nordisk projects.
• B.Pharmacy, M.Pharm, Pharm-D, M.sc
• 4-6 years of experience in the pharmaceutical industry.
• Knowledge of Indian Drug Regulations (D&C Acy, MCMR, ICH etc.). Regulatory Affairs processes and relevant strategies, Clinical research procedures and GCP requirements.
Qualification : B.Pharmacy, M.Pharm, Pharm-D, M.sc
Experience : 4-6 years
Location : Bangalore
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory
End Date : 30th April, 2023
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