Genpact is Hiring in Regulatory Affairs and has issued notification to accept Applications. Genpact (NYSE: G) is a global professional services firm that makes business transformation real. We drive digital-led innovation and digitally-enabled intelligent operations for our clients, guided by our experience running thousands of processes primarily for Global Fortune 500 companies..Application form link provided at the end of post. Eligibility for the Lead Associate – Regulatory Affairs as follows.
Vacancy summary details :
- Company Name: Genpact
- Location : Delhi
- Post Name: Lead Associate – Regulatory Affairs
- Department: Regulatory Affairs
- Qualification: Bachelor’s degree in pharma / Science
- Experience: 1+ years
- No of Vacancies: Not Disclosed by Recruiter
- Details of Salary: Not Disclosed by Recruiter
- Opening date for online Application: 09/03/2021
- Closing date for online Application : Apply as soon as possible
- Date of examination: NA
- Time and Venue :NA
- Mode of application : online
- Selection Process: Shortlisted candidates may called for selection process ( Personal interview , Group discussion , etc…,)
- Contact: NA
Job Description/Skills Required:
The Role demands for a highly qualified professional who should have CMC experience under regulatory affairs domain. Lead Associate will be responsible for all the activities related to –
- Provide input to project regulatory strategies by performing assessments of CMC changes, identifying global regulatory requirements and critically evaluating supporting documentation to assess acceptability and identify potential risks.
- Execute regulatory strategies by leading the development, authoring and review of CMC submission components and documentation to support post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems.
- Collaborate closely with MMD and partners to support compliant execution of organizational change and conduct all activities with an unwavering focus on regulatory conformance.
- Assess and communicate potential regulatory risks and propose mitigation strategies.
- Deliver all regulatory results for assigned products across the product lifecycle
- Identify and communicate potential regulatory issues to GRACS CMC, as needed
- Demonstrated understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance).
- Proven ability to generate innovative solutions to problems and effectively work with and communicate to key partners.
- Proven flexibility in responding to changing priorities or taking care of unexpected events.
- Capability to handle multiple priorities and balance work to achieve business goals.
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.