If you’re looking for a promising career opportunity in Regulatory Affairs, this role at Apotex is worth your attention. Apotex, a globally recognized pharmaceutical company, is hiring for the position of Executive – Global Regulatory Affairs in Mumbai, India.

This role is ideal for candidates with strong knowledge of post-approval submissions, product lifecycle management (PLCM), and regulatory requirements for USFDA, Health Canada, EU, and AUS-NZ markets.

Professionals passionate about regulatory compliance, documentation, and working across global teams will find this opportunity highly rewarding.

🧪 Job Responsibilities

As an Executive, Global Regulatory Affairs, your key responsibilities will include:

• Preparing and reviewing PLCM submissions for US and Canada.
• Ensuring timely regulatory approvals of assigned submissions.
• Compiling and responding to regulatory agency deficiencies.
• Preparing post-approval supplements and variation packages.
• Supporting regulatory compliance activities across US/CAN/EU/AUS-NZ markets.
• Reviewing change control documents and providing regulatory assessment.
• Coordinating with internal teams and third-party manufacturers for submission documents.
• Maintaining regulatory trackers, databases, and documentation systems.
• Drafting or updating applicable SOPs and regulatory guidelines.
• Supporting team members when required and ensuring timely submission of deliverables.

🎓 Eligibility & Qualifications

Education:

✔ Graduate or Post-Graduate in:

• Pharmacy
• Chemistry
• Life Sciences

Experience:

✔ Minimum 3 years of experience in US/CAN/EU/AUS-NZ regulatory markets.

Skills & Competencies:

• Knowledge of post-approval regulatory submissions and variation filing.
• Understanding of pharmaceutical regulatory guidelines and SOPs.
• Strong documentation, communication, and coordination skills.
• Ability to manage multiple submission timelines.

🎯 Why Join Apotex?

• Work with one of the largest Canadian pharmaceutical organizations.
• Contribute to global product lifecycle management initiatives.
• Opportunity to work with high-impact regulatory portfolios.
• Collaborative and compliance-driven work culture.

💼 Job Highlights

Salary range included for schema optimization. Actual compensation may vary.

📩 How to Apply

Application Link