Trainee Regulatory Affairs at Appotex Inc for Freshers

Job Description

As a Trainee in Labelling, Regulatory Affairs at Apotex, you will be responsible for performing labelling update activities and tracking systems for record maintenance related to New Product Development (NPD) label creation and Product Life Cycle Management (PLCM) updates for products in the USA and Canada markets. You will liaise with internal and external stakeholders to understand data queries, coordinate with vendors/affiliates for timely label creation and updates, and ensure quality checks prior to submission to regulatory authorities.

Job Responsibilities:

• Prepare and update prescribing information/product monograph and other labelling components as per regulatory requirements for new drug development or product lifecycle maintenance in the US and Canada markets.
• Author, review, and submit responses for labeling deficiencies received from regulatory agencies within specified timelines.
• Perform activities in accordance with labeling regulatory guidelines for compliance and drug product safety.
• Liaise with international Apotex affiliates and internal departments to discuss submission strategies and maintain project status.
• Coordinate with artwork vendors for labeling creation and updates.
• Initiate and assess change control records using Quality Management System (QMS).
• Maintain and track projects using Regulatory Information Management System (RIMS) and send status notifications to stakeholders.
• Perform quality check review and approval of label artworks using Labeling Artwork Management System (LAMS).
• Create structured product labeling (SPL), validate, and resolve any errors using LabelBridge software.
• Create, review, and compile regulatory documents for labeling components under eCTD Module-1 and submit to USFDA/Health Canada via electronic submission gateway (ESG).
• Ensure effective planning, prioritization, communication, and delivery of quality labelling documents according to company timelines and submission requirements.
• Proofread all types of label copy/annotations at all development stages to ensure accuracy.
• Compile regulatory documents as per USFDA/Health Canada requirements prior to electronic submission.
• Undertake continuous learning, development, and training opportunities to enhance skills and career prospects.
• Collaborate with the team to meet regulatory compliance, safety requirements, and achieve business targets.
• Adhere to all compliance programs, including Global Business Ethics and Compliance Program, Global Quality policies, Safety and Environment policies, and HR policies.
• Perform any other relevant duties as assigned.

Job Requirements: Education: M Pharmacy, B Pharmacy, or Equivalent Degree Knowledge, Skills, and Abilities:

• Basic knowledge and/or understanding of regulatory requirements for filing labeling submissions in USFDA, Health Canada, or ROW markets.
• Good interpersonal communication skills.
• Strong writing skills and ability to compile submission documents.
• Proofreading ability for reviewing technical documents required for dossier preparation.
• Attention to detail to check packaging artwork material and specifications.
• Ability to manage multiple projects/tasks and participate in team-building activities.
• Coordinate with other departments/vendors to ensure timely submission of applications.
• Accountability for assigned projects and prompt responses to queries from various stakeholders or regulatory authorities.
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