"Discover the Exciting Role of a Senior Manager in Regulatory Affairs at Genpact!"

Genpact Regulatory Affairs Job For Pharma

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Job Posting: Senior Manager, Publishing (Submission & Document Publishing)

The Role demands for an experienced Submission Manager with demonstrated ability to execute responsibility in a highly regulated & process driven environment.

Location: Mumbai


  • Candidate should have extensive experience in the respective field.
  • Technical expert on submissions
  • Proven capability to manage the operations and team.
  • Taking care of administrative responsibilities of team
  • Project & resource management
  • Team management and team engagement
  • Should be technical expert in eCTD/CTD submissions of US/EU/Canada and Row market.
  • Hands on experience on submissions
  • Capability to trouble shoot technical validation errors.
  • Good client communication skills
  • Flexible attitude
  • Publishing and performing technical validation (eCTD/CTD/NeeS/Paper) for Asia pacific, Europe Submissions and US submissions.
  • Performing final technical quality review.
  • Dispatching submission to the relevant authority ((eCTD/CTD/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 stakeholders.
  • Capturing submissions-related correspondence from health authorities, such as uploading documentation, commitments and metadata.
  • Co-ordinate with client/stakeholders.


Minimum Qualifications: B. Pham/M.Pharm/Science Graduate

Preferred Qualifications/ Skills

  • Technical Expert on submissions and document publishing
  • Proven skills to Manage team and resources.
  • Handled a direct team of publishers.
  • In depth working knowledge of ECTD/CTD/NEES/Paper types of submission, industry standard publishing systems.
  • Effective time management and organizational skills
  • Effective communication
  • Flexibility to adapt to a changing environment.


Keywords: Genpact, Regulatory Affairs, Pharma, Senior Manager, Publishing, Submission, Document Publishing, Mumbai, Technical Expert.


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