Genpact BSc Life Sciences Lead Associate Job Opening – Apply Online
Genpact BSc Life Sciences Lead Associate Job Opening – Apply Online. BSc Life Sciences Lead Associate job opening at Genpact. Interested and eligible applicants can check out all of the details on the same below
Possible Interview Questions are posted below
Lead associate – Regulatory Affairs –LIF011996
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 US/EU/ROW market.
- Preparation/Updates in CCPI
- System searches for Literature on specific topics (Clinical trials, Articles, Guidelines etc.) provided by client.
- System searches for Competitor Analysis (Gene therapy products, labels etc.) on specific topics provided by client.
- Conducting literature searches to support Product Evaluation Team activities; filter search results; summarize findings to support 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, Labelling EU, and US guidelines.
- Should be advance level in 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.
Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values diversity and inclusion, respect and integrity, customer focus, and innovation. For more information, visit www.genpact.com. Follow us on Twitter, Facebook, LinkedIn, and YouTube.
Possible Interview Questions:
- Can you explain your experience in regulatory affairs and your knowledge of current labelling guidelines in the global market?
- Answer: Certainly. I have X years of experience in regulatory affairs, specifically focusing on labelling guidelines in the global market. I am well-versed in the latest regulations and requirements set by various regulatory bodies.
- How have you evaluated additional local indications in countries not covered in the Common Technical Document Summaries (CCDS) for the US/EU/ROW market in your previous role?
- Answer: In my previous role, I conducted thorough evaluations of local indications in countries not covered in the CCDS. This involved researching and understanding the specific regulatory requirements of those countries to ensure compliance.
- Can you provide examples of conducting literature searches to support Product Evaluation Team activities and summarizing findings to support a specific topic?
- Answer: Yes, during my previous role, I conducted comprehensive literature searches to support Product Evaluation Team activities. I filtered the search results and summarized the relevant findings to provide valuable insights for the team’s decision-making process.
- How familiar are you with the Common Catalogue of Medicinal Products Information (CCPI), competitor analysis, and labelling guidelines in the EU and US markets?
- Answer: I have extensive knowledge of the CCPI, competitor analysis techniques, and labelling guidelines in both the EU and US markets. I understand the importance of staying updated with the latest regulatory requirements and ensuring compliance with them.
- How do you prioritize and manage multiple priorities in regulatory affairs to achieve business goals?
- Answer: Prioritization and time management are crucial in regulatory affairs. I have developed effective strategies for managing multiple priorities by assessing their importance, setting clear goals and deadlines, and collaborating with cross-functional teams to ensure alignment and efficient workflow.
Note: The answers provided are general examples and can be customized based on the candidate’s specific experience and expertise.
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