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Assistant Manager - CMC PA CHANGES

3.00 to 5.00 Years   Mumbai City   22 Dec, 2020
Headstrong
Job LocationMumbai City
EducationNot Mentioned
SalaryNot Disclosed
IndustryIT - Software
Functional AreaGeneral / Operations Management
EmploymentTypeFull-time

Job Description

AM, CMC PA ChangesIn this role, you will work on ICH guidelines and CTD Structure & Expertise with Publishing Tools like Liquent , Docubridge, etc. 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
,

Keyskills :
salesmisaccountstatbankingms officepostingmusic makingcustomer focusdigital conversioncommunication skillsverbal communication

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