Genpact BSc Life Sciences Associate Job Opening, Apply Online

Genpact BSc Life Sciences Associate Job Opening, Apply Online

Genpact BSc Life Sciences Associate Job Opening, Apply Online. BSc Life Sciences candidates apply. Interested and eligible candidates can check out all of the details regarding the same below:

Possible Interview Questions for the role of Lead Associate – Regulatory Affairs at Genpact are posted below

Job: Lead Associate – Regulatory Affairs (LIF011998)

Primary Location: India-Mumbai

Schedule: Full-time

Education Level: Bachelor’s / Graduation / Equivalent

Master Skills List: Operations

Job Category: Full Time

With a startup spirit and 115,000+ curious and courageous minds, we have the expertise to go deep with the world’s biggest brands—and we have fun doing it! We dream in digital, dare, and reinvent the ways companies work to make an impact far bigger than just our bottom line. We are harnessing the power of technology and humanity to create meaningful transformation that moves us forward in our pursuit of a world that works better for people.

Now, we are calling upon the thinkers and doers, those with a natural curiosity and a hunger to keep learning, keep growing. People who thrive on fearlessly experimenting, seizing opportunities, and pushing boundaries to turn our vision into reality. And as

you help us create a better world, we will help you build your own intellectual firepower.

Welcome to the relentless pursuit of better.

Inviting applications for the role of Lead Associate, Regulatory Affairs for Labelling for Global market!

You should have a relevant year of experience in regulatory affairs with must knowledge of current labelling guidelines in Global Market.

Responsibilities

In this role, you will be responsible for:

• Evaluation of additional local indications in countries not covered in the CCDS for the US/EU/ROW market.
• Preparation/Updates in CCPI
• System searches for Literature on specific topics (Clinical trials, Articles, Guidelines etc.) provided by the client.
• System searches for Competitor Analysis (Gene therapy products, labels etc.) on specific topics provided by the client.
• Conducting literature searches to support Product Evaluation Team activities; filter search results; summarize findings to support the topic.

Qualifications we seek in you!

Minimum Qualifications

• Bachelor’s degree, preferably in Pharmacy, Medicine, Chemistry, or related Life science discipline required with relevant experience in the pharmaceutical industry.
• Mandatory Knowledge of ICH and FDA guidelines for the US market.
• Knowledge of CCDS, CCPI, Competitor Analysis, and Labelling EU, and US guidelines.
• Should be advanced level in the English language.

Preferred Qualifications/ Skills

• Good people and customer handling skills
• Effective leadership, communication, and interpersonal skills.
• Capability to handle multiple priorities and balance work to achieve business goals.
• Enthusiasm & Confidence
• Adhere to our principles and values.
• Time Management skills

APPLY ONLINE

Possible Interview Questions for the role of Lead Associate – Regulatory Affairs at Genpact:

1. Can you describe your experience in regulatory affairs and your knowledge of current labelling guidelines in the Global Market?
   • Answer: I have [X] years of experience in regulatory affairs, specifically focusing on labelling guidelines in the Global Market. I am well-versed in the regulatory requirements set by different regulatory authorities and stay updated with the latest guidelines to ensure compliance.
2. How familiar are you with CCDS, CCPI, and Competitor Analysis in the context of regulatory affairs?
   • Answer: I have extensive knowledge of CCDS (Company Core Data Sheet), CCPI (Company Core Patient Information), and Competitor Analysis. These tools and practices play a crucial role in ensuring accurate labelling and staying competitive in the market. I have utilized them in my previous roles to assess and align our labelling strategies.
3. Can you provide an example of a challenging situation you faced in evaluating additional local indications in countries not covered in the CCDS for the US/EU/ROW market? How did you handle it?
   • Answer: In one instance, I encountered a situation where there were local indications for a specific country that were not covered in the CCDS. To address this, I conducted thorough research, consulted with relevant stakeholders, and proposed an amendment to the labelling strategy to include these indications while ensuring compliance with regulatory guidelines. This involved coordinating with cross-functional teams and obtaining necessary approvals.
4. How do you stay updated with the latest regulatory guidelines and industry trends in labelling?
   • Answer: I prioritize continuous learning and stay updated by regularly monitoring regulatory authority websites, attending industry conferences and seminars, and subscribing to reputable publications. Additionally, I actively participate in professional networks and engage in discussions with regulatory experts to exchange knowledge and insights.
5. Can you discuss your experience in conducting literature searches to support Product Evaluation Team activities? How do you filter and summarize the findings effectively?
   • Answer: I have conducted literature searches to support Product Evaluation Team activities by utilizing various databases, scientific journals, and online resources. To filter the search results, I apply relevant keywords and filters to obtain the most relevant and reliable information. I then critically analyze the findings, extract key insights, and summarize them concisely to support the team’s decision-making process.

Remember, these answers are provided as a guideline, and it’s important to tailor them to your specific experiences and qualifications when preparing for an interview.

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