Regulatory Affairs Specialist

TCS is hiring for Regulatory Affairs Role !!! Location : Mumbai Experience : 5 to 8 years Job Description : 1) Minimum 5 to 8 Years experience in Regulatory Affairs with minimum 2 Years direct exposure in Regulatory Publishing. 2) Candidates should have hands-on experience in eCTD, CTD, ACTD, NeeS submission Experiences. 3) Candidates must be exposed with IND, NDA, BLA, MAA, ANDA, sNDA, CTA, PIP type of submissions. 4) Should be well versed with gateway requirements; CESP, ESG, EMA etc. 5) Good knowledge on Publishing tools; Veeva, eCTD express, Docubridge, Pharmaready etc 6) Experience in publishing troubleshooting 7) Good communication skills Best Regards, Megha Dixit TCS - HR