Lead Consultant - Publishing
Mumbai, India
22h ago


The Role demands for an expert 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 (eCTD / NeeS) for US, LATAM and Canadian Submissions.
  • 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 acknowledgement from authority of submission receipt;
  • capturing and the electronic receipt and metadata in RIM; communicating 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. Pharm / Science Graduate
  • Preferred qualifications

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