Baxter Recruitment September 2020.Baxter International Inc. is an American multinational health care company with headquarters in Deerfield, Illinois. The company primarily focuses on products to treat hemophilia, kidney disease, immune disorders and other chronic and acute medical conditions.
Important Vacancy details:
- Post Name: Regulatory Affairs Officer
- Location: Ahmedabad, Gujarat, India
- Salary :NA
- Openings :NA
Note:If Intrested Candidates Can Submit the Resume Above Email id.
Job Description: We have requirement for the post of Regulatory Affairs Officer in Baxter !
To preferably know how to deal with FDA and IPO, PDEA and DENR regulations
· To be responsible for evaluation and submission of New product Dossier to FDA.
· To prepare and file documents for initial application, variations and renewals
· To evaluate and assess completeness & quality of initial registration documents and requirements as per ACTD guidelines
· To check artworks for new products and also for commercial products before shipments
· To be responsible for checking NOD (Notice of Deficiency) from FDA and providing response to FDA in a timely manner
· To be responsible to liaise and submit necessary applications, and to follow up for all applications from FDA ,PDEA and DENR to get approvals within timeline
· To handle FDA related matters such as proper compliance with standard regulations on licenses, technical documents, and product registrations, and to be able to submit compliance on or before the deadline FDA
· To ensure that the company’s products comply with the regulations of the FDA & PDEA
· To prepare semi- annual report, 1st & 2nd notices and local & import permit applications for PDEA submission for Securing Import permit and local permit in timely manner
· To be responsible for preparing CPR renewal and variation application
Selection Process: The selection will be on the basis of Interview.
How to Apply : Click here for full details and Apply Online