Regulatory Affairs Specialist

4 weeks ago


Mumbai, India Tata Consultancy Services Full time
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 etc6) Experience in publishing troubleshooting7) Good communication skills

Best Regards,Megha DixitTCS - HR

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