Assistant Manager - CMC PA CHANGES

Responsibilities

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 (eCTD/NeeS) for US, LATAM and Canadian Submissions.

Performing final technical quality review and technical validation (eCTD/NeeS)

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