Assistant Manager - Labeling

Job Summary

• Support GBS GRA labelling team for preparation, compilation and review of applications submitted to Health Canada and US FDA
• Maintenance of documentation/database records pertaining to products, in line with systems, processes and procedures
• Monitors and reports on the progress/status of submissions, planned changes to the Reporting Manager
• Review assigned applications to ensure all documents involved are of high quality and error free, to facilitate One Cycle review. Documents should be in line with expectations from Regulatory agency and in compliance with regulatory guidelines
• Leading and/or coordinating regulatory affairs projects, as assigned.

Job Responsibilities

• Review, compilation and timely submissions of applications to Health Canada. Ensure all documents required for New Product filings are available on DocuBridge as per agreed timeline
• Responsible to respond to queries received for assigned products from Health Canada/USFDA within given timeline & with high quality
• Building applications into eCTD format and ensure documents meet strict internal and regulatory standards
• Applications/documents are of high-quality standard to ensure one cycle review from Regulatory authorities
• Support reporting manager in developing submission strategies and building technical knowledge within team
• Ensure preparation of all required forms and documents for submission projects for Health Canada
• Ensure applications are peer reviewed (as per agreed timeline) and comments are addressed as soon as possible to facilitate DocuBridge upload for final publishing
• For Artwork management, create the BLUE Project for Non-Commercial and Commercial Workflow
• Create and update the RIMS record, CCR-QMS, LAMS-BLUE projects to reflect current status
• As part of application compilation process, ensure to follow process like raising BLUE request and preparing Text Compare Reports for verification of Package Insert
• Verification of Labels through proof compare tools in BLUE for approval of Labels
• Handling of Common Electronic Submission Gateway (ESG) for submission of applications for US & Canada market
• Accountable to support overall functioning of team and support reporting manager as and when required
• Act as a support to reporting manager for planning and execution of trainings to newly joined team members
• Effectively communicate and collaborating with team member for achieve all outcomes
• Timely complete all assigned training in training portal
• Timely communication and follow up with the respective departments for compilation and submission of new product submissions and query responses to meet agreed timeline
• Provides regulatory support to stakeholders as & when required
• Co-ordinate with third party vendors like Freyr for artworks and BLUE update/approvals
• Works with internal and external stakeholders to resolve issues related to information for regulatory submissions and change control documentation
• 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/ Science

• Knowledge, Skills and Abilities
  • Knowledge and/or understanding of regulatory requirements for filing labelling applications to USFDA, Health Canada or ROW markets
  • Should have excellent verbal & written communication skills
  • Ability to be flexible and multi-task in a rapidly changing environment
  • Demonstrate good writing skills and compilation of submission documents
  • Proof-reading ability for reviewing technical documents required for dossier preparation
  • Attention to detail to check packaging artwork material and specifications Collaborate with team members
  • Self-motivated, taking responsibility and taking initiative

• Experience
  • Candidate should have minimum 6 years of labelling experience in US, Canada, Europe or ROW market