[Freshers] Trainee Regulatory Affairs at Apotex Inc

Job Title: Trainee – Labelling, Regulatory Affairs at Apotex Inc.
Location: Mumbai
Salary: Rs. 22,000 per month
Experience: 0-1 years

Company Overview:
Apotex Inc. is a global health company dedicated to producing affordable, high-quality medicines for patients worldwide.

Position Overview:
Join Apotex as a Trainee in Labelling, Regulatory Affairs. Responsibilities include labelling updates, record maintenance, and coordination with stakeholders for regulatory compliance.

Job Responsibilities:

Responsibility	Details
Prepare and update labelling components for new drug development or product lifecycle maintenance.	Ensure compliance with regulatory guidelines for drug safety.
Author, review, and submit responses for labelling deficiencies.	Collaborate with internal/external stakeholders for timely submissions.
Liaise with affiliates and departments for submission strategies.	Coordinate with vendors for labelling creation and updates.
Initiate and assess change control records.	Maintain project status using regulatory systems.
Perform quality check review and approval of label artworks.	Ensure accuracy of label copies at all development stages.
Create, review, and compile regulatory documents for submission.	Submit to regulatory authorities via electronic submission gateway.
Plan, prioritize, and communicate effectively for timely deliveries.	Undertake continuous learning and development.
Adhere to compliance programs and company policies.	Collaborate with the team to meet regulatory requirements.
Perform other relevant duties as assigned.

Job Requirements:

• Education: M Pharmacy, B Pharmacy, or equivalent degree.
• Knowledge of regulatory requirements for USFDA, Health Canada, or ROW markets.
• Strong communication, writing, and proofreading skills.
• Attention to detail and ability to manage multiple projects.