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
B. Pharm / Science Graduate
Excellent written and verbal communication skills
Proficient in MS Office applications, especially in MS excel