Edge Pharma

EDGE PHARMA is a pharmaceuticals company based out of 213, ANJANI COMPL ANDHERI, Mumbai, Maharashtra, India.

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1 Job openings at Edge Pharma

Regulatory Affairs Executive

Mumbai Suburban

4 - 6 years

INR 3.0 - 5.5 Lacs P.A.

Work from Office

Full Time

Exp.: Min 4 to 5 years Designation: Executive- Regulatory Affairs Location: Mumbai Must have Key Skills: CTD/ ACTD/ CMC/ technical review/ Dossier/ MOH queries/ Variations/ Renewals Other essential skills: LATAM/ GCC/ MENA/ SEA/AFRICA/ change control/ Art work checking Job description: Common requirements: 1) Complete understanding of requirements & regulations of ASEAN/ AFRICA/LATAM/ GCC/ MENA markets wrt New submissions, Re-registration & Variations. 2) Prior experience of carrying out high quality CMC review of all kind of technical documentation & Art-works, 3) Review and /or Compilation of country specific/ CTD/ACTD dossiers for new submissions & renewal. 3) Variations submission 4) Must be an Individual contributor + Good team player. Specific requirements: 1) Collate, compile & author high quality CTD sections for M1, M2, M3, M4 & M5. 2) Detailed review of technical documents required for Regulatory submissions e.g. PVP/PVR/AMV/Stability report & Protocol/Specifications/ COAs/ BE study/ DMF etc. 3) Coordinate with Plant for required documents/ samples/ working standards etc. through emails/ phone calls for smooth running of Projects. 4) Utmost care is recommended to minimize the unwanted errors while working with documents i.e. authoring & reviewing the data. Preferred candidate profile Female and Male

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Edge Pharma

Pharmaceutical Manufacturing

12345 City

11-50 Employees

1 Jobs

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