Drug Regulatory Affairs
Drug Regulatory Affairs19
Applications
19
Applications
Not Accepting Applications
About the Job
Skills
Position Name : Drug Regulatory Executive(DRA Executive)Only Female Candidates needed.
Candidates Having The Central Drugs Standard Control Organization(CDSCO) experience and similar with these organizations can apply.
compiling comprehensive dossiers, and reviewing technical documents such as AMV, MFR, PVPR,
BMR, STS, STP, COA, stability reports, protocols, and API documents. Seeking a challenging role to leverage this experience and drive
regulatory excellence.
Form 8, Form 12, Form 16, Form 19, Form 40 & Form 42
Form CT-04, CT-16 & CT-18
Form MD-14, MD-16, MD-22, MD-24, MD-26 & MD-28
Preparation of Informed Consent Documents
Preparation & Submission of Post approved and various
applications on SUGAM portal
To prepare data about a new product for doctors and other healthcare professionals for harmless and effective practice of medicine and maintain records, and reports of post-marketing surveillance of the new product. It also helps to prepare the leaflets and advertising material for existing as well as new drugs.
Documentation for Italy, Brazil,Belgium,USA.
Required Expertise: Stability Data , Process Validation, Pharmacovigilance,
Job Types: Full-time, Regular / Permanent
Job Type: Full-time
Pay: ₹30,000.00 - ₹35,000.00 per month
About the company
Industry
Management Consulting
Company Size
11-50 Employees
Headquarter
Noida , Uttar Pradesh
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