Cipla Life Sciences Job Opening For BSc & MSc Candidates, Apply Online
Cipla Life Sciences Job Opening For BSc & MSc Candidates, Apply Online. Graduate/Post Graduate in Life Sciences Jobs. Interested and eligible applicants can check out all of the details on the same below
Hey job seeker, if you are wondering what kind of interview questions you may have to answer for the role of Team Member – CDT at Cipla then make sure you reach the end of the page for those tidbits!
Name of the Post – Team Member – CDT
Requisition ID – 75992
Location – India – Maharashtra – Vikhro
Division – IPD
Department – IPD
Employment Type – Permanent
Job Purpose
Compile dossier in accordance with regulatory strategy, manage deficiencies, evaluate products and submit tenders to ensure adherence to regulatory requirement for various regulated/international markets within agreed timelines
Accountabilities
- Review documents and compile and handover quality dossier as per enforcement of/updates in regulatory guidelines for various regulated/ international market, so as to minimize deficiencies from the health authority
- Evaluate and compile quality deficiency response to all regions to meet the targeted timelines of the health authorities/customers.
- Assess and submit product evaluation and tender documents to regional teams for DRF conversion and product commercialization
- Adopt and disseminate information on new regulatory guidelines through ongoing training and interaction with regional teams to minimize deficiencies
Education Qualification
Graduate/Post Graduate in Pharmacy or Life Sciences
Relevant Work Experience
5 years in the field of Regulatory Affairs/Quality Assurance
Competencies/Skills
- Communication Skills (clarity of thought, comprehension)
- Likely potential for growth
- Job / Product / Technical Knowledge / Pharma domain knowledge
- Presentation & Interpersonal skills (If applicable)
- Managerial or People Management skills
- Safety awareness (If applicable)
- Relevance of Previous Experience
- Comprehension, Analytical & Problem solving abilities
- Productivity & Result Orientation (If applicable)
- Attitude
- Qualification fitment
- Sales drive (If applicable)
- Personality traits (Individualistic / Team player, Out spoken, Maturity level etc.)
Hey you, before you run off to apply for this role, do check out the possible interview questions and their answers for the Team Member – CDT role at Cipla.
- Can you describe your experience in compiling dossiers according to regulatory guidelines for regulated and international markets? How have you ensured adherence to regulatory requirements within specified timelines?
- Answer: In my previous role in Regulatory Affairs, I have been responsible for compiling dossiers in accordance with regulatory guidelines for various markets. I have closely followed updates in regulations and ensured that the dossier is compliant and free from deficiencies. I have maintained a thorough understanding of the specific requirements for each market and worked diligently to meet the timelines set by health authorities.
- How have you managed quality deficiency responses to health authorities or customers in the past? Can you provide an example of a challenging deficiency response and how you addressed it?
- Answer: As part of my role in Regulatory Affairs, I have evaluated and compiled quality deficiency responses to meet the timelines set by health authorities and customers. In one instance, we received a deficiency letter regarding product safety data. To address this, I collaborated with cross-functional teams to gather and analyze the necessary data. I organized and presented a comprehensive response that addressed all concerns raised by the health authority, ensuring that the response was of high quality and submitted within the required timeframe.
- Can you discuss your experience in evaluating and submitting product evaluation and tender documents for regional teams? How have you contributed to the conversion of documents for product commercialization?
- Answer: I have been involved in evaluating product evaluation and tender documents as part of the regulatory process. I have worked closely with regional teams to assess the documentation requirements and ensure their completion. I have facilitated the conversion of documents into the required format for Drug Registration Filings (DRF) and played a key role in the commercialization of products by providing the necessary regulatory support.
- How do you stay updated with new regulatory guidelines? Can you provide an example of how you have disseminated this information to regional teams and minimized deficiencies as a result?
- Answer: Staying updated with new regulatory guidelines is crucial in Regulatory Affairs. I actively participate in ongoing training programs and engage in continuous learning to remain abreast of the latest regulations. When new guidelines are introduced, I have facilitated training sessions and conducted interactive discussions with regional teams to ensure a clear understanding of the changes. By disseminating this information effectively, we have been able to minimize deficiencies and maintain compliance with regulatory requirements.
- How have you demonstrated your comprehension, analytical, and problem-solving abilities in your previous roles in Regulatory Affairs?
- Answer: In my previous roles, I have consistently utilized my comprehension, analytical, and problem-solving abilities to navigate complex regulatory challenges. For instance, I have analyzed regulatory requirements, identified gaps or issues, and devised effective solutions to ensure compliance. I have also conducted comprehensive assessments of product data and documents, identifying potential areas of improvement and implementing appropriate strategies to address them.
Note: These are sample questions and answers. It is important to personalize the answers based on the individual’s experience and expertise in Regulatory Affairs.
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