Specialist - Regulatory Affairs - Operations 4A

Overview

Publish and technically validate eCTD submissions for US regulatory filings and manage post-submission processing in a highly regulated, process-driven environment.

What you'll do

• Publish and perform technical validation of eCTD for US submissions.
• Perform final technical quality review.
• Dispatch submissions to the relevant authority (eCTD/CTD/NeeS/Paper) or to affiliates for dispatch to the authority.
• Perform post-submission processing, including receiving authority acknowledgement of submission receipt.
• Capture electronic receipts and metadata in RIM and communicate submission receipt to key stakeholders.
• Capture submission-related correspondence from health authorities, such as uploading documentation, commitments and metadata.

What you'll need

• Bachelor's degree in Health Administration, Healthcare or Pharmacy, or Master's degree in Public Health or Regulatory Affairs.
• Language: English, intermediate (B1).
• Skills: Client Relations, Collaboration Tools, Data Analytics, Generative AI, Lean Six Sigma (LSS), People Leadership, Personal Effectiveness, Storytelling.

Nice to have

• Certified Compliance Officer (CCO) - Vskills.
• Certified Public Accountant (CPA) - Perfekt Szolnok.
• Certified Regulatory and Compliance Professional (CRCP) - JSS University.
• Certified Regulatory Compliance Manager (CRCM) - The International Association of Risk and Compliance Professionals (IARCP).

Details

• Location: 7th floor, Raiaskaran Tech Park, Sakinaka, Mumbai, India.
• Job type: Regular.
• Work mode: Office work.
• Shift: Night shift (India).