Apotex Inc. is inviting applications for the position of Analyst, GBS GRA PLCM at its Mumbai location. This Regulatory Affairs job in Mumbai focuses on product life-cycle management (PLCM), regulatory compliance, and post-approval submission management across global markets.
Apotex, headquartered in Toronto, is one of the largest Canadian pharmaceutical companies, known for its generic, biosimilar, and innovative branded products. This opportunity is ideal for pharmacy and life sciences graduates seeking to build a career in regulatory affairs and pharmaceutical product life-cycle management.
📌 Job Details
- Job Title: Analyst, GBS GRA PLCM
- Location: Mumbai, Maharashtra (400079)
- Department: Global Regulatory Affairs – Product Life Cycle Management
- Experience Required: Minimum 1 year
- Education: Graduate/Postgraduate in Pharmacy, Chemistry, or Life Sciences
🔬 Key Responsibilities – Regulatory Affairs & PLCM
The Analyst – GBS GRA PLCM role involves:
- Preparation of post-launch PLCM regulatory submission packages for global markets
- Maintenance and updating of regulatory documentation and databases
- Preparation and submission of approval notifications to regulatory agencies
- Compilation and coordination of deficiency responses within agreed timelines
- Evaluation and preparation of post-approval supplements
- Review and assessment of change control documents
- Maintenance of regulatory trackers (deficiency tracker, submission spreadsheet, review checklist)
- Coordination with third-party manufacturers for submission documentation
- Ensuring compliance with SOPs, RA policies, and regulatory guidelines
- Cross-functional collaboration with Quality, Manufacturing, and Supply teams
- Drafting and reviewing regulatory SOPs (as applicable)
This Regulatory Affairs Analyst job in Mumbai provides hands-on exposure to regulatory product lifecycle management across multiple international markets.
🎓 Qualifications & Skills Required
Educational Qualification:
- B.Pharm / M.Pharm
- M.Sc. in Chemistry or Life Sciences
- Other relevant scientific degrees
Required Skills:
- Understanding of pharmaceutical company departments
- Knowledge of Regulatory Affairs processes and PLCM activities
- Familiarity with regulatory software systems
- Experience in handling regulatory databases and documentation systems
- Strong coordination and communication skills
🌟 Why Join Apotex?
Apotex offers:
- Exposure to global regulatory affairs operations
- Structured regulatory lifecycle management experience
- Collaborative and innovation-driven work culture
- Strong focus on ethics, compliance, and quality
- Equal opportunity and accessible work environment
For professionals seeking growth in pharmaceutical regulatory affairs jobs in Mumbai, this is a strategic opportunity.
📩 How to Apply
