If you’re a B.Pharm or M.Pharm graduate eager to start a career in pharmaceutical labeling and regulatory affairs, here’s your chance!
Apotex, a leading Canadian-based global pharmaceutical company, is hiring for the Trainee, Labeling position in Mumbai, Maharashtra, India. This role is ideal for freshers and early-career professionals passionate about regulatory labeling, artwork management, and compliance for US and Canada markets.
About Apotex
Apotex Inc. is a Canadian-based global health company dedicated to improving access to affordable, high-quality medicines. With a wide portfolio of generic, biosimilar, and innovative pharmaceutical products, Apotex operates across North America, Latin America, and Asia, making it the largest Canadian-owned pharma company.
Website: www.apotex.com
Job Overview
As a Trainee – Labeling, you will support New Product Development and Product Lifecycle Maintenance by preparing, updating, and coordinating labeling materials for USFDA and Health Canada submissions. You’ll collaborate with internal teams, vendors, and affiliates to ensure all label updates meet regulatory and quality standards.
Key Responsibilities
- Prepare and update labels and monographs for US and Canada markets.
- Coordinate with vendors and affiliates for artwork creation and updates.
- Maintain tracking systems such as RIMS, CCR, and internal trackers.
- Perform ESG submissions and manage acknowledgments.
- Author responses and make decisions regarding label change applicability.
- Prioritize labeling requirements and plan timely submissions.
- Support regulatory document compilation and process improvement initiatives.
- Stay updated with new labeling regulations and guidelines.
- Uphold Apotex’s corporate values: Courage, Collaboration, Perseverance, and Passion.
Required Qualifications
Education:
- Bachelor’s or Master’s degree in Pharmacy (B.Pharm/M.Pharm).
Skills & Abilities:
- Understanding of regulatory requirements for USFDA and Health Canada.
- Strong communication and writing skills.
- Excellent attention to detail and proofreading ability.
- Capability to manage multiple projects effectively.
- Familiarity with labeling software and artwork management tools.
- Proactive and accountable in coordinating with vendors and stakeholders.
Experience:
- Theoretical knowledge or exposure to labeling activities for US or Canada markets preferred.
Why Join Apotex?
- Work with a global leader in pharmaceuticals.
- Gain hands-on experience in regulatory labeling and lifecycle management.
- Collaborative and inclusive workplace culture.
- Opportunities for professional growth and cross-functional learning.
- Exposure to international labeling compliance standards.
How to Apply
