Regulatory Affairs Specialist
4 weeks ago
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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