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
| Category | Details |
|---|---|
| Job Role | Executive – Global Regulatory Affairs |
| Company | Apotex |
| Location | Mumbai, Maharashtra, India |
| Work Type | Full-Time |
| Experience Required | Minimum 3 years |
| Salary (Estimated Range) | ₹6,50,000 – ₹12,00,000 per annum |
Salary range included for schema optimization. Actual compensation may vary.
📩 How to Apply
