Senior Analyst – Regulatory Labeling
Location: Mumbai, Maharashtra, India (400079)
Date Posted: January 9, 2026
Employment Type: Full-time
Company: Apotex
Industry: Pharmaceuticals | Regulatory Affairs | Labeling
Apotex is a Canadian-based global pharmaceutical company committed to improving access to affordable, high-quality medicines and healthcare products worldwide. With a diverse portfolio spanning generic, biosimilar, innovative branded pharmaceuticals, and consumer health products, Apotex serves patients across more than 75 countries. Headquartered in Toronto, Canada, with major operations in the United States, Mexico, and India, Apotex is the largest Canadian-owned pharmaceutical company and a trusted partner for global licensing and product acquisitions.
Learn more at: www.apotex.com
Apotex is seeking a Senior Analyst – Regulatory Labeling to support regulatory labeling activities for the Canada market, with exposure to US labeling requirements. The role is responsible for end-to-end label creation, updates, and lifecycle maintenance for new and existing products. This position requires close collaboration with internal regulatory teams, vendors, affiliates, and health authorities to ensure accurate, compliant, and timely labeling submissions throughout the product lifecycle.
Coordinate and prepare regulatory labeling submissions for the Canada market in alignment with Health Authority requirements
Create, review, and maintain product labels and product monographs for New Product Development and Product Lifecycle Management (Canada and US)
Prepare and submit supporting documentation for various labeling submission types
Coordinate with vendors, points of contact, and affiliates for timely artwork creation and updates
Maintain labeling trackers and regulatory systems including RIMS, CCRs, and internal tracking tools
Author regulatory responses and assess applicability of labeling changes based on regulatory feedback
Review assigned labeling tasks and ensure completion of project management and quality checklists
Prioritize labeling activities and plan submissions based on regulatory timelines and business priorities
Maintain working knowledge of labeling software systems and LAMS processes
Interact with cross-functional teams including Regulatory Affairs, Project Management, Quality, and Affiliates
Stay current with Canadian and international labeling regulations and guidelines
Support ESG submissions and ensure accurate documentation maintenance
Train new team members on labeling systems, tools, and processes
Ensure compliance with global quality systems, regulatory standards, business ethics, safety, and environmental policies
Master’s degree (2 years) in Pharmacy with specialization in Pharmacology
OR
Bachelor’s degree (4 years) in Pharmacy
Minimum 3–5 years of experience in Regulatory Affairs with a strong focus on Regulatory Labeling
Prior experience in pharmaceutical labeling for the Canada market is essential
Experience working in Global Regulatory Affairs (GRA) or labeling teams within pharmaceutical organizations is preferred
Strong experience in eCTD dossier compilation and regulatory submissions
Working knowledge of Canadian labeling regulations and lifecycle management requirements
Proficiency in labeling systems and regulatory tracking tools (LAMS, RIMS, tracking sheets)
Good understanding of regulatory documentation, artwork coordination, and submission workflows
Strong written and verbal communication skills with the ability to collaborate cross-functionally
Proficient in MS Excel, PowerPoint, and other MS Office applications
Ability to prioritize tasks, manage multiple projects, and meet regulatory timelines
High attention to detail and commitment to submission quality and compliance
At Apotex, we foster an inclusive, ethical, and performance-driven work culture where employees are empowered to contribute meaningfully to global healthcare. We are committed to diversity, accessibility, and professional growth, providing a supportive environment where talent can thrive.
Apotex provides reasonable accommodation throughout the recruitment process. Applicants requiring accommodation during interviews or assessments are encouraged to inform the recruitment team.
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