Trainee, Labeling
📍 Location: Mumbai, Maharashtra, India (470009)
📅 Date Posted: October 9, 2025
🏢 Company: Apotex Inc.
About Apotex Inc.
Apotex is a Canadian-based global healthcare company dedicated to improving everyday access to affordable and innovative medicines for millions worldwide.
With a broad portfolio that includes generic, biosimilar, and innovative branded pharmaceuticals, as well as consumer health products, Apotex is Canada’s largest pharmaceutical company.
Headquartered in Toronto, the company operates regional offices in the United States, Mexico, and India, serving as a trusted health partner for pharmaceutical licensing and product acquisitions.
🌐 Learn more: www.apotex.com
Job Summary
As a Trainee in Labeling, you will support the label update, maintenance, and creation activities for products in the US and/or Canada markets.
Your role involves coordinating with internal teams, affiliates, and vendors to ensure accurate and timely labeling submissions that meet Health Authority (HA) requirements.
Key Responsibilities
Prepare and update labels and monographs for new drug development and product lifecycle maintenance in the US/Canada markets.
Compile and submit supporting documents for labeling submissions according to regulatory requirements.
Coordinate with Points of Contact (POC) and vendors for artwork creation and updates.
Maintain tracking tools such as RIMS, CCRs, and tracking sheets to ensure timely submission of label updates.
Perform ESG submissions and maintain acknowledgment records.
Author responses and make decisions regarding label change applicability.
Prioritize labeling tasks and plan submissions based on urgency and regulatory timelines.
Participate in process improvement initiatives within the department.
Maintain effective communication with affiliates, internal departments, and Health Authorities.
Keep up-to-date with labeling regulations and international guidelines.
Support and embody Apotex’s core values: Courage, Collaboration, Perseverance, and Passion.
Ensure compliance with all regulatory, quality, and safety standards.
Perform other duties as assigned.
Education
🎓 Required: Graduate or Postgraduate degree in Pharmacy (B.Pharm / M.Pharm).
Knowledge, Skills, and Abilities
Basic understanding of regulatory labeling requirements for USFDA, Health Canada, or other markets.
Strong written and verbal communication skills.
Proficiency in document proofreading and technical review for labeling dossiers.
Attention to detail when reviewing packaging artwork and specifications.
Strong organizational and multitasking abilities.
Ability to coordinate across departments and vendors to meet submission timelines.
Accountability for assigned projects with prompt and professional response handling.
Familiarity with labeling software and document management systems.
Experience
Theoretical understanding of labeling activities for US or Canada markets is essential.
Core Competencies
Team collaboration and effective communication
Quality focus and accuracy
Process compliance and documentation discipline
Initiative in learning and regulatory awareness
Work Environment & Inclusion
Apotex is committed to providing a welcoming, accessible, and inclusive workplace where all employees feel valued, respected, and supported.
Accommodations for applicants with disabilities are available upon request during the recruitment process.
Join Us
Be part of a global team driving healthcare accessibility and innovation.
Help deliver safe, high-quality medicines that make a difference in people’s lives.
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China | Quarry Bay |Liaoning :
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Canada |Quebec :
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Brazil | Sao paulo |Attica :
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Madrid |Cebu Province :
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Croatia |Zagreb :
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Japan | Saitama |Tokyo :
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