Senior Analyst – Regulatory Labeling
Location: Mumbai, Maharashtra, India – 400079
Company: Apotex Inc.
Date Posted: February 7, 2026
Employment Type: Full-Time
Industry: Pharmaceuticals | Regulatory Affairs | Labeling & Compliance
About Apotex Inc.
Apotex is a Canadian-based global health company dedicated to improving access to affordable, innovative medicines worldwide. Our portfolio spans generic, biosimilar, innovative branded pharmaceuticals, and consumer health products. Headquartered in Toronto, with regional offices in India, United States, and Mexico, Apotex is the largest Canadian pharmaceutical company and a trusted partner for pharmaceutical licensing and product acquisitions.
Learn more: www.apotex.com
Job Summary
The Senior Analyst – Regulatory Labeling is responsible for managing label creation, updates, and regulatory compliance for products in the Canadian market. This role supports New Product Development (NPD) and Product Life Cycle (PLC) maintenance, interacts with internal compilers, vendors, and affiliates, and ensures timely submission of labels to Health Authorities. The ideal candidate will have experience in regulatory labeling, dossier submissions, and artwork coordination, combined with a strong knowledge of Canadian labeling regulations and global compliance standards.
Experience Required
3–4 years of experience in regulatory labeling, life sciences, or pharmaceutical operations
Prior experience with eCTD compilation, product lifecycle management, and labeling submissions
Experience in GRA labeling teams or regulatory operations preferred
Educational Qualification
Master’s in Pharmacy (Pharmacology specialization) – Minimum 2 years experience
Bachelor’s in Pharmacy – Minimum 4 years experience
Key Responsibilities
Regulatory Labeling & Compliance
Prepare and submit regulatory labeling dossiers and supporting documents for Canada
Ensure labels and monographs comply with product lifecycle updates and new drug development requirements
Maintain all tracking requirements, including RIMS, tracking sheets, and CCR
Vendor & Affiliate Coordination
Collaborate with vendors, affiliates, and internal stakeholders for artwork creation, label updates, and Health Authority queries
Negotiate and communicate effectively to ensure timely regulatory approvals
Labeling Review & Quality Assurance
Review labeling submissions, ensure PM and form checklists are completed
Author responses and determine applicability of labeling changes
Define priority of labeling requirements and plan submissions accordingly
Technical & Process Expertise
Maintain user-level proficiency in LAMS software and labeling tools
Stay current on international labeling guidelines and regulatory changes
Provide training to new hires on labeling processes and software
Collaboration & Compliance
Work safely and collaboratively with cross-functional teams
Adhere to Global Business Ethics, Quality Policies, Safety & Environment policies, and HR regulations
Required Skills & Competencies
Strong knowledge of Canadian labeling regulations, eCTD dossier compilation, and regulatory processes
Experience with MS Office, Excel, PowerPoint, and digital labeling systems
Effective communication, organizational, and presentation skills
Knowledge of animal assays, molecular biology techniques (PCR, DNA extraction, cloning) is a plus
Ability to prioritize tasks and manage multiple labeling projects
Core Competencies
Regulatory Knowledge & Compliance
Process Excellence & Attention to Detail
Collaboration & Stakeholder Management
Strategic Planning & Result Orientation
Training & Mentorship
Why Join Apotex?
Contribute to global regulatory labeling and compliance for leading pharmaceutical products
Work with a cross-functional team in a dynamic, regulated environment
Enhance expertise in labeling software, regulatory submissions, and global compliance
Be part of an organization committed to innovation, ethical standards, and employee development
Inclusion & Accessibility:
Apotex provides accommodations for applicants with disabilities during recruitment. Candidates requiring support for interviews or assessments are encouraged to inform the recruitment team.
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