Project Leader, Labeling-Global Regulatory Affairs

Job Summary

This position is responsible for managing all activities relating to the preparation, submission and post-approval requirements for FDA-related label submissions.  The individual will support artwork reviews and approvals, National Drug Code (NDC) assignments, website content maintenance, and compliance activities. This role ensures the accuracy, consistency, and regulatory compliance of labeling documentation and product information throughout the product lifecycle while coordinating activities across multiple electronic document management and quality systems.

Job Responsibilities

• Review, evaluate, analyze and recommend actions on all regulatory issues relating to US labelling operations.
• Maintain up to date knowledge on regulatory requirements to assure compliance with current regulations and apply to Apotex Corp. operations.
• Review, compare, and approve product artworks to ensure compliance with approved labeling and regulatory requirements. Identify artwork discrepancies and reject artwork when necessary, providing detailed corrections and feedback for resolution.
• Initiate Change Control Requests (CCR) through the Quality Management System (QMS) and coordinate artwork updates through Blue.
• Assign new National Drug Code (NDC) numbers based on approved requests and established company procedures.
• Maintain NDC records by updating document repositories and routing information for necessary approvals.
• Maintain product labeling information on company websites by creating and managing naming conventions for newly marketed products. Upload and maintain current labeling documents, including Package Inserts (PI), Medication Guides (MG), and Patient Information Leaflets (PIL), as applicable.
• Perform periodic audits of website product information to ensure accuracy and consistency with approved product listings.
• Responsible for active status reporting of NDA and ANDA to FDA.
• Support regulatory compliance initiatives by maintaining accurate documentation and records.
• Collaborate with cross-functional teams to ensure timely implementation of labeling changes and product information updates.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Integrity, Courage, Teamwork, and Innovation.
• 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
  • Bachelor's degree in Life Sciences, Regulatory Affairs, Pharmacy, Chemistry, Biology, or a related scientific discipline preferred.
  • Equivalent combination of education and relevant experience may be considered.
• Knowledge, Skills and Abilities
  • Knowledge of pharmaceutical labeling regulations and regulatory submission requirements.
  • Familiarity with Structured Product Labeling (SPL) processes and health authority requirements.
  • Working knowledge of document management, quality management, and regulatory information management systems.
  • Strong attention to detail and ability to identify inconsistencies in labeling and artwork.
  • Excellent organizational and time management skills with the ability to manage multiple projects simultaneously.
  • Strong written and verbal communication skills.
  • Proficiency in Microsoft Office applications.
  • Ability to work independently and collaboratively in a cross-functional environment.
  • Demonstrated problem-solving and analytical skills.
• Experience
  • 5-7 years of experience in pharmaceutical labeling, regulatory affairs, quality systems, or related regulated industry experience preferred.
  • Experience reviewing and approving labeling artwork preferred.
  • Experience in guiding team members with respect to department activities and goals through direction and review of assigned tasks. Uses independent judgment and creativity in achieving assigned department objectives.
  • Experience using electronic document management and quality systems preferred.
  • Experience maintaining regulatory records and documentation in a GxP environment preferred.