Analyst GBS GRA PLCM Job at Apotex Mumbai
Apotex is hiring an Analyst, GBS GRA PLCM in Mumbai for product life-cycle management and regulatory affairs operations. This Analyst Job opportunity is ideal for pharmacy and life sciences graduates with regulatory systems experience who want to grow in global pharmaceutical compliance and post-approval submissions. Graduates seeking B Pharma jobs or M Pharma jobs can apply now.
- Job Title: Analyst, GBS GRA PLCM-GBS-PLCM G
- Location: Mumbai, Maharashtra, India (400079)
About the Company
Apotex Inc. is a Canadian-based global health company committed to improving access to affordable and innovative medicines worldwide. With a broad portfolio of generic, biosimilar, branded pharmaceuticals, and consumer health products, Apotex operates globally with headquarters in Toronto and major offices in the United States, Mexico, and India. It is the largest Canadian-based pharmaceutical company and a preferred health partner across the Americas. This Analyst Job role plays a significant role in the company.
Key Responsibilities
- Prepare quality post-launch PLCM packages for various markets to ensure timely regulatory approvals.
- Maintain and complete regulatory documentation in compliance with global requirements.
- Assess, coordinate, and compile deficiency responses within agreed timelines.
- Work cross-functionally to resolve regulatory submission issues.
- Evaluate and prepare post-approval supplements for life-cycle management.
- Review change control documents and provide regulatory assessments.
- Maintain regulatory databases, trackers, checklists, and submission spreadsheets accurately.
- Coordinate with third-party manufacturers for documentation support.
- Act as a back-up for team members when required.
- Communicate and follow up with departments to meet submission timelines.
- Interpret and comply with SOPs, regulatory policies, and guidelines.
- Draft SOPs and regulatory guidelines when applicable.
- Communicate with external agents and suppliers for submission-related data.
- Demonstrate organizational values: Integrity, Teamwork, Courage, and Innovation.
- Ensure adherence to ethics, quality, safety, environmental, and HR policies.
Educational Requirements
-
Post-graduate or Graduate degree in Pharmacy
Skills Required
- Understanding of pharmaceutical company departments and cross-functional coordination.
- Knowledge of regulatory affairs activities and product life-cycle management.
- Familiarity with regulatory software systems and documentation tools.
- Strong documentation, compliance, and database management skills.
- Good communication and coordination abilities.
Experience
A candidate should have a minimum of 1 year of experience in handling various systems used by regulatory professionals.
Why This Job Role?
This Analyst Job position offers hands-on exposure to global regulatory life-cycle management, post-approval submissions, and compliance strategy in a multinational pharmaceutical company. It is a strong career-building opportunity for professionals aiming to grow in Regulatory Affairs and global pharma operations. Graduates seeking B Pharma jobs or M Pharma jobs can apply now.
