Regulatory Affairs Executive

Job Description

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