Apotex Hiring in Regulatory Affairs

Job Posting: Regulatory Affairs Labeling Executive at Apotex

Company: Apotex
Position: Regulatory Affairs Labeling Executive
Location: Mumbai
Experience: 1-2 Years
Qualification: B.Pharm, M.Pharm, M.Sc, B.Sc
Salary: Not disclosed

About Apotex:
Apotex Inc., a global healthcare leader based in Canada, is renowned for producing high-quality, affordable medicines. With a workforce of nearly 7,200, Apotex operates in over 75 countries, focusing on the development and marketing of generic, biosimilar, and specialty products.

Role Overview:
The Regulatory Affairs Labeling Executive will oversee labeling updates and maintenance for new product development and lifecycle management, particularly for the Canadian market. This role involves close collaboration with various teams to ensure timely preparation and submission of accurate labeling materials to health authorities.

Key Responsibilities:

Responsibility	Details
Regulatory Submissions & Strategies	Coordinate and prepare submissions, ensuring compliance with Canadian labeling standards.
Document Preparation	Collect and submit documentation, coordinate with vendors, and update artwork.
Tracking & Maintenance	Maintain tracking needs, including RIMS, tracking sheets, and CCRs.
Label Updates	Prepare and update labels/monographs for the US and Canadian markets.
Regulatory Knowledge	Stay informed on Canadian regulations, handle final product submissions, and communicate with regional teams.

Knowledge, Skills, and Abilities:

• Basic understanding of regulatory requirements for labeling submissions (US FDA, Health Canada, or ROW markets).
• Excellent communication and interpersonal skills.
• Strong attention to detail, especially in reviewing technical documents and packaging artwork.
• Ability to work collaboratively within teams.
• Self-motivated with a proactive approach to tasks.
• Experience with labeling in any market (US, Canada, Europe, or ROW).