Executive, GBS GRA NPD&RI

Job Summary

• Compilation and submission of new registration applications, deficiency responses and pre-launch variations for assigned products
• Maintenance of documentation/database records pertaining to products, in line with systems, processes and procedures
• Supporting and/or coordinating regulatory affairs projects, as assigned
• Preparation of submission and approval notifications for new product applications submitted to Regulatory agencies.

Job Responsibilities

• Support in review and compilation of applications (i.e., ANDA, Co-dev applications and ANDS) of drug products to Health authorities of US and Canada market.
• Support in review and compilation of deficiency packages for assigned products of US/Canada market within given timeline & with high quality measured against compiler checklist maintained by team.
• Review and compilation of New Product applications for international markets as assigned.
• Building dossier/applications into eCTD format and ensure documents meet strict internal and regulatory standards
• Ensure dossier/documents are of high-quality standard to ensure one cycle review from Regulatory authorities
• Support in review and compilation of supplements/pre-launch variations (e.g. CBE, CBE-30, PAS, sANDS and Level -III) for assigned products
• Maintain records in global regulatory databases and in established trackers (Review checklist for NPD/deficiency response/ pre-launch variation, deficiency tracker, status sheet etc.) and ensure accuracy of information
• Handling of Common Electronic Submission Gateway (ESG) for submission of applications for US & Canada market
• In depth (detailed) review of all technical documents required for compilation of New Product Submission (NPD - ANDA/ANDS), Pre-launch variations and query responses before sending it for final review.
• Completion of all the assigned trainings in timely manner.
• Actively work to suggest, develop and obtain own Key Performance Measures (KPMs) in conjunction with Reporting Manager
• Ensure compliance with SOPs and regulatory guidelines published from time to time by respective regulatory agencies
• Act as a back-up for team members and support as and when required
• Review of change control forms and provide accurate assessment for change being assessed (as applicable and assigned)
• Timely communication and follow up with the respective departments for compilation and submission of new product submissions, query responses & pre-launch variation to meet agreed timeline
• Provides regulatory support to stakeholders as & when required
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.

Job Requirements

• Education:
  • A Postgraduate/Graduate in pharmacy.
• Knowledge, Skills and Abilities:
  • Candidate should have knowledge about NPD submission requirement and compilation of dossier for US/Canada market.
• Experience:
  • Candidate should have minimum 3 years of experience in US / Canada market.