Novo Nordisk Hiring MPharm Candidates. Apply Now!
Novo Nordisk, a global healthcare company renowned for its commitment to diabetes care, is actively seeking talented M.Pharm candidates to join their team as Regulatory Associates. This is a fantastic opportunity to contribute to groundbreaking advancements in pharmaceuticals and make a meaningful impact on patient lives. Apply now to be a part of this dynamic organization!
Job Title: Regulatory Associate
Category: Regulatory
Location: Bangalore, Karnataka, IN
Department: Clinical Medical Regulatory (CMR)
Deadline of Application: 27th September 2023.
Novo Nordisk Hiring M.Pharm. The required qualifications are :
- All life science graduates are eligible but preference to M.pharm candidates.
- 1-3 years of total 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.
Roles and Responsibilities:
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.
Novo Nordisk Hiring M.Pharm candidates. The possible interview Q & A to help you with:
Question: Can you describe your experience with preparing and compiling documents for regulatory submissions?
Answer: In my previous role at [Previous Company], I was responsible for preparing and compiling documents for regulatory submissions for new drugs and clinical trials. I ensured that all required documents were meticulously organized and met the specified timelines. This experience has equipped me with a strong understanding of the documentation process necessary for regulatory approvals.
Question: How do you ensure the quality control of health authority submission dossiers before submission?
Answer: Quality control is a critical aspect of regulatory submissions. I always perform a thorough review of the submission dossier to ensure accuracy and compliance with regulatory requirements. I cross-check documents for completeness, consistency, and adherence to internal and external guidelines. This practice helps minimize the risk of errors and delays in the submission process.
Question: How do you proactively identify potential queries from health authorities, and how do you handle them?
Answer: I proactively anticipate potential queries from health authorities by closely reviewing submission materials and staying updated on regulatory guidelines. When I identify possible issues, I promptly communicate them to relevant stakeholders such as Medical, Commercial, and CDC Trial managers. This collaborative approach allows us to address potential queries efficiently and resolve them before submission.
Question: Can you share an example of a challenging situation where you had to secure regulatory approvals within tight timelines?
Answer: In my previous role, we faced a situation where a clinical trial needed regulatory approval urgently due to unforeseen delays in the study timeline. To address this challenge, I worked closely with cross-functional teams, expedited document preparation, and maintained constant communication with health authorities. Through these efforts, we successfully secured the necessary approvals within the tight deadline.
Question: How do you stay updated with evolving regulatory requirements and changes in the pharmaceutical industry?
Answer: Staying updated with regulatory changes is crucial in the pharmaceutical industry. I regularly participate in industry conferences, webinars, and seminars. Additionally, I subscribe to relevant regulatory newsletters and journals to stay informed about evolving requirements. This commitment to ongoing learning ensures that I can adapt quickly to changes in the regulatory landscape and apply them to my role effectively.
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