Genpact Hiring 2022 .Genpact Notification full details below.Interested and eligible candidates can Apply Now.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.
- Post Name: Lead Consultant – Regulatory Affairs
- Qualification: B. Pharmacy / M. Pharmacy / B.Sc. / M.Sc.
- Experienced: Experience in regulatory affairs while essential exposure to the lifecycle document management (LCM) and also need to have good knowledge of ICH guidelines and post-approval submissions and regulations.
Job Description: Genpact Hiring For Lead Consultant – Regulatory Affairs !
Important Details :
- Post of date:01/09/2022
- Location: India-Mumbai
- Selection Process: The selection will be on the basis of Interview.
Roles and Responsibilities
In this role, you will be responsible for:
1. Responsible for implementing CMC regulatory strategies for assigned consumer products in accordance with global regulations, guidance and defined regulatory strategies.
2. Responsible for the writing of CMC quality documents for the dossier and/or the entire module 3 from raw data.
3. Review and evaluation of existing quality documentation and assessment of required updates during Project Renewals.
4. Preparation of Quality Overall Summaries (QOS) for drug product and drug substance.
5. Compilation of dossiers for launch applications for marketing authorization and new drug applications in Global markets.
6. Submission of relevant sections in Annual Reports for US Market.
7. Preparing RA expert response for deficiency letters from various regulatory authorities;
8. Assessment of registration documentation for consumer products as per the current Health Authority requirements.
9. Knowledge of review and assessment of manufacturing, analytical, validation and stability documents.
10. Post-approval submission knowledge for EU markets
How to Apply :
Step 1: Click on below link and you will be redirected to Career Page of Recruiting Company or Career portal.
Step 2. Register on Career Page of the Company or Career Portal by giving log in credentials and other personal or education details .
Step 3.Upon successful registration .User need to log in with credentials.
Step 4.Once logged in, User need to fill the all relevant personal ,educational , Work experience details ,attach resume and submit application form.