Senior Analyst – Regulatory Labeling
Location: Mumbai, Maharashtra, India
Job Type: Full-Time
Company: Apotex Inc.
Date Posted: Jan 28, 2026
About Apotex
Apotex Inc. is a leading Canadian global pharmaceutical company committed to improving patient access to affordable and innovative medicines. With a diverse portfolio of generic, biosimilar, and branded pharmaceuticals, Apotex operates in over 75 countries, including India, the US, and Mexico. Headquartered in Toronto, Apotex is recognized as the largest Canadian-based pharmaceutical company, specializing in regulatory excellence, product lifecycle management, and global health solutions.
Learn more at: www.apotex.com
Role Overview
We are seeking a Senior Analyst – Regulatory Labeling to join our Global Regulatory Affairs (GRA) Labelling Team in Mumbai. This role focuses on label creation, lifecycle updates, and regulatory compliance for products in the Canada and US markets. The ideal candidate will coordinate with internal teams, vendors, and affiliates to ensure timely, accurate, and compliant labeling submissions in alignment with health authority requirements.
Key Responsibilities
Coordinate and prepare regulatory submissions related to labeling for new product development and product lifecycle maintenance.
Ensure timely creation and updates of artwork in collaboration with vendors, affiliates, and cross-functional teams.
Interact with compilers and internal teams to resolve data-related queries and track project progress.
Maintain all tracking systems and tools (RIMS, tracking sheets, CCR) to ensure on-time submissions to health authorities.
Author and review labels and monographs in compliance with Canadian and US regulations.
Manage ESG submissions and provide guidance on labeling changes, making informed decisions on applicability.
Prioritize labeling requirements and plan submissions based on regulatory timelines and project urgency.
Maintain user-level expertise in labeling software (LAMS) and support training for new team members.
Stay updated on international labeling regulations, guidelines, and industry best practices.
Collaborate with internal departments and demonstrate organizational values: Collaboration, Courage, Perseverance.
Adhere strictly to global compliance programs, quality policies, safety, and HR guidelines.
Required Skills & Competencies
Proficiency in MS Office (Excel, PowerPoint, Word) and internet-based research tools.
Experience with dossier submissions via eCTD/Docubridge.
Knowledge of molecular biology techniques (gel electrophoresis, plasmid & genomic DNA extraction, transformation, cloning, PCR) and basic animal assay methods.
Strong communication, presentation, and organizational skills.
Ability to work collaboratively, manage multiple projects, and meet deadlines.
Self-motivated, detail-oriented, and committed to regulatory compliance excellence.
Education & Experience
Master’s in Pharmacy (M.Pharm) or Bachelor’s in Pharmacy (B.Pharm), or equivalent degree.
1–3 years of experience in Regulatory Affairs, preferably in pharmaceutical labeling or product lifecycle management.
Why Join Apotex
Be part of a global pharmaceutical leader improving access to life-saving medicines.
Work with cross-functional teams and international regulatory stakeholders.
Opportunities for career growth in regulatory affairs and labeling management.
Supportive, inclusive, and accessible work environment fostering learning and professional development.
Apply today on thepharmadaily.com to join as a Senior Analyst – Regulatory Labeling and advance your career in global regulatory affairs.a
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