Novo Nordisk is a Denmark-based multinational with leadership in diabetes. Novo Nordisk India affiliate office is in Bangalore & has more than 1,400 people working across the country in various functions. The latest Lifescience RA Job details are provided below. Apply online if you are eligible. Latest Lifescience RA Job.
Job role – Regulatory Associate
Location: Bangalore, Karnataka, IN
Department: Clinical Medical Regulatory (CMR)
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.
- All life science graduates are eligible but preference to Mpharma candidates.
- 1-3 years of total exp 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.
Hello, everyone! We’ve gathered a collection of interview questions and their corresponding answers to aid you in your interview readiness. Feel free to use this resource to enhance your performance during the interview for the Latest Lifescience RA Job.
1. Can you describe your experience in preparing and compiling documents for regulatory submissions of new drugs and clinical trials?
In my previous role as a Regulatory Associate, I was responsible for preparing and compiling documents for various regulatory submissions, including new drugs and clinical trial applications. This involved collaborating closely with cross-functional teams to ensure all required documents were complete and submitted within agreed timelines. I have a strong understanding of the documentation requirements, and I consistently ensured compliance with regulatory guidelines throughout the submission process.
2. How do you ensure the quality control of Health Authority (HA) submission dossiers before submission?
Quality control of HA submission dossiers is a critical step in the regulatory process. I take a meticulous approach to this task by thoroughly reviewing each document and ensuring that they meet the required standards and specifications. I also use a checklist to verify that all necessary documents are included and that they are accurate and up-to-date. This attention to detail helps minimize the risk of errors or omissions in the submission.
3. How do you proactively identify potential queries from Health Authorities and collaborate with relevant stakeholders to address them?
To proactively identify potential queries from Health Authorities, I closely review the submission documents from their perspective. I anticipate questions or concerns they may have and communicate these to relevant stakeholders, including Medical, Commercial, CDC Trial managers, and HQ RA CTA management team. This proactive approach allows us to prepare well-thought-out responses in advance, ensuring a smoother regulatory approval process.
4. Can you provide an example of a situation where you successfully secured regulatory approvals for clinical trials or new products within agreed timelines?
Certainly. In a previous project, we had a tight timeline for securing regulatory approvals for a clinical trial. I worked closely with the team to ensure all required documents were in order and submitted promptly. Through effective coordination and proactive communication with Health Authorities, we were able to obtain the necessary approvals within the agreed-upon timeline. This allowed the clinical trial to proceed as planned, demonstrating my ability to meet regulatory deadlines.
5. How do you stay updated with changes in Indian drug regulations and other relevant regulatory affairs knowledge?
I stay updated with changes in Indian drug regulations and relevant regulatory affairs knowledge by regularly monitoring updates from regulatory agencies, such as the Drugs and Cosmetics Act (D&C Act), MCMR, and ICH guidelines. I also participate in industry seminars, workshops, and conferences to stay informed about the latest developments. Additionally, I maintain a network of regulatory contacts and colleagues to exchange information and best practices. This commitment to continuous learning ensures that I stay current with regulatory requirements and industry trends.