Genpact BSc Life Sciences Lead Associate Job Opening – Apply Online
Lead associate – Regulatory Affairs –LIF011996
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.