Regulatory Affairs Manager Job In Arch Recruiting Solutions In Mumbai City, Navi Mumbai

Current Openings-1- Regulatory Affairs Executive andManagerPost- 2Exp: Min 2 to 10 years Qualification: B Pharm/ M Pharm 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/ Artwork 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 in carrying out high quality CMC reviews of all kinds 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 eg PVP/PVR/AMV/Stability report & Protocol/Specifications/ COAs/ BE study/ DMF etc 3) Coordinate with Client/ Plant for required documents/ samples/ working standards etc through emails/ phone calls for smooth running of Projects.

4) Utmost care is recommended to minimize unwanted errors while working with documents ie authoring & reviewing the data

Arch Recruiting Solutions is looking for .

Arch Recruiting Solutions is looking for Any Graduate / Post Graduate profile candidates.