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Lead consultant - Annual Report SP

Zoek Pin Mumbai, Maharashtra

Permanent (Full time)

The Role demands a specialist Publisher with proven ability to execute responsibility in a highly regulated & process-driven environment, the Person will be responsible for all the activities related to- Performing final technical quality review and technical validation for US, LATAM and Canadian Submissions.

  • Performing final technical quality review and technical validation
  • Dispatching submission to the meaningful authority (eCTD, NeeS, paper) or affiliate so that affiliate can dispatch to authority;
  • Performing post-submission processing activities such as receiving acknowledgment from the authority of submission receipt; capturing and the electronic receipt and metadata in RIM; presenting submission receipt to key partners;
  • Capturing submissions-related correspondence from health authorities, such as uploading documentation, commitments and metadata.

Qualifications we seek in you
Minimum qualifications - B. Pham/Science Graduate

Preferred qualifications

  • Excellent written and verbal communication skills
  • Proficient in MS Office applications, especially in MS excel

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