Novo Nordisk insulins have been present in India from 1935 marking more than 80 years of uninterrupted supply. The India arm started operations in 1992 with its headquarters in Bengaluru. We now have over 1.300 employees, and are the 5th largest and one of the fastest growing pharmaceutical MNCs in India. Our growth is your opportunity to create a life-changing career in an expanding organisation. Our best-in-class product portfolio and strong product pipeline create a dynamic working environment, where strong cross-functional collaboration is essential.
Name of Position: Regulatory Associate
Job Description
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.
Candidate Profile
- 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.
Location: Bangalore
Industry Type: Pharma / Healthcare / Clinical research
Functional Area: Regulatory
End Date: 30th April, 2023
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