Novartis is Hiring in Regulatory Affairs and has issued notification to accept Applications.Novartis is a global healthcare company based in Switzerland that provides solutions to address the evolving needs of patients worldwide. Eligibility for the Multiple Position as follows.
Vacancy summary details :
- Company Name: Novartis
- Location :Mumbai
- Post Name: Executive/ Senior Executive – Regulatory Affairs
- Department: Regulatory Affairs
- Qualification: Bachelor’s degree,Post graduate degree
- Experience: 2 to 4 years
- No of Vacancies: Not Disclosed by Recruiter
- Details of Salary: Not Disclosed by Recruiter
- Opening date for online Application: 29/01/2021
- 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…,)
Job Description/Skills Required:
Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements for New Drug Application for drugs and/or biologics
• Provide submission and contribute to the technical related regulatory strategy, intelligence and knowledge required to develop, register, and maintain global products. Exposure in Global clinical trial applications or India-specific clinical trial application will be an advantage.
• Post approval compliances for Global clinical trials including Protocol amendment submissions, amendments in Investigator’s brochure, IMPD, Investigators, addition of site(s) etc
• Post approval compliances for New Drugs including PSUR submissions, CMC variation submissions etc
• Registration certificate (RC) application and Import licence (IL) applications including variations like shelf-life amendment, storage conditions amendment and all similar CMC variations including renewals of RC/IL, where approval/notification is required to the Indian HA
• A good expertise on the HA portal SUGAM. Understanding of how to navigate in SUGAM for various submissions is essential.
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.
Click here for notification and Apply
