Senior Analyst – Labeling Job at Apotex Mumbai
Apotex is hiring a Senior Analyst – Labeling in Mumbai, India, to support regulatory labeling activities for the Canada market. This Analyst Job role focuses on new product development, lifecycle maintenance, and health authority submissions, offering strong exposure to global regulatory operations within a leading pharmaceutical organization. Graduates seeking for B pharma jobs or M Pharma jobs can apply now.
Job Details
- Job Title: Senior Analyst – Labeling
- Location: Mumbai, Maharashtra, India (400079)
About the Company
Apotex is a Canadian-based global health company dedicated to improving access to affordable, innovative medicines worldwide. With a broad portfolio spanning generics, biosimilars, innovative branded pharmaceuticals, and consumer health products, Apotex is the largest Canadian pharmaceutical company and a trusted partner across global markets.
Educational Requirements for the Analyst Job Role
-
M.Pharmacy / B.Pharmacy or equivalent degree
Key Responsibilities
- Perform labeling update and maintenance activities for New Product Development and product lifecycle management
- Prepare and submit supporting documents for labeling submissions to Health Canada
- Coordinate with compilers, vendors, and affiliates for artwork creation and label updates
- Maintain labeling trackers and systems including RIMS, tracking sheets, and CCR
- Preparing and updating labels and product monographs for US and Canada markets is required for this Analyst Job role
- Develop and maintain regulatory knowledge specific to Canada
- Manage final product submissions and communicate with regional teams and health authorities
- Author responses and assess applicability of label changes
- Review assigned tasks to ensure quality, checklist completion, and submission accuracy
- Prioritize labeling requirements and plan submissions accordingly
- Maintain working knowledge of labeling and LAMS software
- Stay updated with new labeling regulations and international guidelines
- Train new team members on labeling systems and processes
- Ensure compliance with global quality, ethics, safety, and regulatory policies
Skills Required for the Analyst Job Role
- 1–3 years of experience in Regulatory Affairs
- Hands-on experience with eCTD submissions using DocuBridge
- Knowledge of labeling lifecycle management and Canada regulatory requirements
- Familiarity with RIMS, tracking tools, and labeling software
- Strong documentation, organizational, and communication skills
- Proficiency in MS Excel, PowerPoint, MS Office, and digital tools
- Ability to work collaboratively across internal teams and external partners
Why This Job Role?
This Analyst Job role provides direct exposure to global labeling operations, Health Canada submissions, and lifecycle management for pharmaceutical products. It is ideal for Regulatory Affairs professionals seeking to build strong expertise in labeling strategy, cross-functional coordination, and international regulatory compliance within a global pharmaceutical company. Graduates seeking for B pharma jobs or M Pharma jobs can apply now.
