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Opportunity to work as Regulatory Associate at Novo Nordisk – M.Pharm, B.Pharm, M.Sc Apply

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Website Novo Nordisk

Novo Nordisk is a leading provider of diabetes care with 89 years of innovation. The business also holds top positions in the fields of growth hormone therapy, hormone replacement therapy, and haemophilia care.

Post: Associate in Regulatory Affairs.

Job Description The Position 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.
  • Knowledge of Indian Drug Regulations (D&C Acy, MCMR, ICH etc.). Regulatory Affairs processes and relevant strategies, Clinical research procedures and GCP requirements.

Candidate Profile

Qualifications and Experience: B.Pharmacy, M.Pharm, Pharm-D, M.sc • 4-6 years of experience in the pharmaceutical industry.

Place: Bangalore

Industrial type: Pharmaceutical, healthcare, and clinical research

Functional Area: Regulatory Functional Area

Last Date to apply: 30 April 2023Top of Form

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To apply for this job please visit www.novonordisk.co.in.