Job Details

Asst. Manager - IRA with Pharma Co. based at Ahmedabad
Date Posted :21-05-2020 12:24:34
Job Ref Code : NS

Contact Name : Rina Arun
The Post Applied For : Asst. Manager - IRA with Pharma Co. based at Ahmedabad
City : Ahmedabad
State :
Country : 0
Requirement Type : Domestic
Functional Areas : Poduction
Industry : Pharma/Biotech/Clinical Research
Level : Middle
Qualification : D. Pharm OR B. Pharma
Job Responsibilities :
Collect and coordinate information and compile regulatory documentation for 1. submission to regulatory agencies or to commercial partners, advise on the submission strategy 2. Preparation & compilation of dossier in ACTD, CTD & country specific format according to guidelines of various countries. 3. Response to query/deficiency/Notice of Deficiency (NOD) raised by Drug Regulatory Authority or technical representative. 4. Coordination with Quality Control, Quality Assurance and Production department for regulatory documents. 5. Timely compile documents for license renewals, update and re-registrations Maintain regulatory files/database and chronologies in good order. 6. Product Permit 7. Food & Drug Related work 8. COPP 9. Renewal of licence 10. WHO GMP work with CDSCO
Candidate Profile :
Desired candidate who has 7+ experience of IRA with Various Countries in Pharma Company.
Other Skills Required :
Age : 22 - 30
Experience : 7 Year
Other Skills Required :