Officer/Executive - Regulatory Affairs job in Vadodara by SKY MANAGEMENT CONSULTANCY for 3 - 5 Years Experience

Officer/Executive - Regulatory Affairs

SKY MANAGEMENT CONSULTANCY

3 Years - 5 Years
5.00 - 8.50 Lacs p.a.
Vadodara

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Posted: 19/06/2023

Job Description

Regulatory Affairs

Designation Level : Officer/Executive

Experience Required : 3 to 6 years

Education : B. Pharm / M. Pharm

Job Location : Padra , Dist : Vadodara,Gujarat

For CMC reviewer and compilation
-Compilation and submission of eCTD dossier for new product application (ANDA/EU-MA)/Post approval submission to the regulatory authority (specifically EU/US)
-Hand on experience in preparation of CTD section as per regulatory requirements of different region
-Having experience in preparation of query response and PAS, CBE and annual report.
-Have ability to co-ordinate with cross functional team
-Having experience for Drug listing and annual updates
-Having ability to review documents as per current regulatory guidelines.

Job Information

Job Type: Full Time
Industry: Biotechnology/Pharmaceutical/Medicine
Function : Legal/Law
Specilizations: Regulatory Affairs
Key Skills: ectd regulatory affairs euctd compilation cmc regulatory guidelines new product regulatory requirements

About Company

SKY MANAGEMENT CONSULTANCY
We are hiring this position for one of Pharmaceutical client based at Padra Baroda. Manufacturing Pharma Formulations Products.