Senior Analyst – Labelling
Location: Mumbai, Maharashtra, India – 400079
Company: Apotex Inc.
Job Type: Full-Time
Posted On: November 17, 2025
About Apotex
Apotex Inc. is a Canadian-based global healthcare company committed to improving access to affordable, innovative medicines and health products worldwide. With a broad portfolio including generic, biosimilar, and branded pharmaceuticals, Apotex serves millions globally. Headquartered in Toronto, with offices in the United States, Mexico, and India, Apotex is recognized as the largest Canadian pharmaceutical company and a trusted partner for pharmaceutical licensing and product acquisitions.
For more information, visit: www.apotex.com
Position Overview
The Senior Analyst – Labelling will support regulatory labelling updates and maintenance for new product development and lifecycle management in the Canada market. This role involves coordination with internal teams, affiliates, and vendors, ensuring timely creation and submission of labelling artwork in compliance with regulatory requirements.
This position is open to fresher candidates with a pharmaceutical background who are eager to build a career in regulatory affairs and labelling compliance.
Key Responsibilities
Regulatory Labelling Management
Coordinate and prepare regulatory submissions for labelling in compliance with Canada regulatory requirements.
Prepare and submit all supporting documentation for labelling updates and new product submissions.
Collaborate with Points of Contact (POC) and vendors for artwork creation and timely delivery.
Maintain all tracking tools, including RIMS, tracking sheets, CCR, to ensure timely submissions.
Update labels and monographs as part of new product development or product lifecycle maintenance.
Monitor and maintain knowledge of Canadian labelling regulations and international guidelines.
Quality & Compliance
Author responses and make decisions regarding label changes.
Ensure all submissions meet internal quality standards with PM and form checklists completed.
Demonstrate compliance with all regulatory, safety, and ethical guidelines.
Train new joinees on LAMS software and labelling processes.
Collaboration & Reporting
Interact with regional teams, internal departments, and regulatory authorities to resolve queries.
Support data-enabled decision-making and ESG submissions.
Prioritize labelling requirements and plan submissions based on critical timelines.
Candidate Profile
Education:
M. Pharmacy, B. Pharmacy, or equivalent degree.
Skills & Competencies:
Knowledge of eCTD dossier compilation via Docubridge.
Basic understanding of molecular biology techniques (PCR, DNA extraction, cloning).
Proficiency in MS Office, including Excel and PowerPoint.
Strong communication, presentation, and organizational skills.
Attention to detail and ability to follow SOPs and regulatory guidelines.
Experience:
Fresher candidates are encouraged to apply.
Exposure to regulatory affairs, labelling, or pharmaceutical documentation is a plus.
Why Join Apotex
Build expertise in regulatory affairs and pharmaceutical labelling.
Opportunity to work with a global pharmaceutical company and expand professional growth.
Inclusive, accessible, and supportive workplace culture.
Hands-on experience in Canada market labelling regulations and eCTD submissions.
Equal Opportunity Commitment
Apotex is committed to fostering a diverse, inclusive, and accessible workplace. All qualified applicants receive equal consideration, and accommodations are available during the recruitment process for candidates with disabilities.
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