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NTT Data Vertex Software Inc. The Manager Regulatory Affairs will be responsible to guide, mentor and trouble shoot team on regulatory submissions pathways.,-The candidate should b.....

NTT Data Vertex Software Inc. Bengaluru ₹ NA 10-12Y JobType object (1)
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Job Description
  • The Manager Regulatory Affairs will be responsible to guide, mentor and trouble shoot team on regulatory submissions pathways
  • -The candidate should be well versed in Regulatory Affairs with good experience in CMC authoring , MAT, post approval maintenance activities like renewals, variations, annual reports, change control pertaining to EU and US markets
  • -Knowledge on eRIMS tools
  • -Also, he should be good in communication and writing skills and should be able to lead and train junior colleagues
  • QualificationsPost graduate in pharmacy/life sciences with around 10-12 years of relevant experience working on regulatory Affairs
  • Minimum 2-3 years of experience in the line management role.
Job Summary
The Manager Regulatory Affairs will be responsible to guide, mentor and trouble shoot team on regulatory submissions pathways.,-T
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Key Skills
maintenance activities line management