Apotex is hiring for the position of Senior Analyst – Product Life Cycle Management (PLCM) in Mumbai, Maharashtra. The role focuses on regulatory submissions, product life-cycle management, change-control assessment, and regulatory compliance for products marketed in the US and Canada.
Candidates with a graduate or postgraduate degree in Pharmacy, Chemistry, or Life Sciences and at least 1 year of relevant regulatory experience may be eligible for this opportunity.
Job Overview
| Details | Information |
|---|---|
| Company | Apotex |
| Position | Senior Analyst – Product Life Cycle Management |
| Job Type | Full-time |
| Location | Mumbai, Maharashtra |
| Experience | Minimum 1 year |
| Qualification | Graduate/Postgraduate in Chemistry, Pharmacy or Life Sciences |
| Markets | US / Canada / EU / Australia-New Zealand |
| Function | Regulatory Affairs / Product Life Cycle Management |
| Job Posted | September 17, 2026 |
About Apotex
Apotex is a Canadian-based global health company involved in generic, biosimilar, innovative branded pharmaceutical and consumer health products. The company operates internationally, including through its India operations.
Senior Analyst – PLCM Job Responsibilities
The selected candidate will support new product submissions and product life-cycle management activities for Apotex products. Key responsibilities include:
- Prepare and review quality regulatory PLCM submissions for US and Canadian markets.
- Support preparation of New Product Development (NPD) submissions.
- Prepare submission and approval notifications for regulatory agencies.
- Prepare pre-approval and post-approval supplements where applicable.
- Assess assigned change-control documents and determine appropriate regulatory requirements.
- Maintain regulatory databases, trackers and documentation accurately.
- Coordinate with third-party manufacturers to obtain documents required for submissions.
- Follow up with internal departments for timely compilation of PLCM submissions and query responses.
- Interpret and comply with SOPs, regulatory policies and applicable guidelines.
- Assist with drafting SOPs and regulatory guidelines when required.
- Communicate with agents, suppliers and other external stakeholders regarding submission data.
- Work with internal departments to address regulatory issues and submission-related requirements.
- Provide backup support to other team members when required.
Apotex Senior Analyst PLCM Qualification
Applicants should have a graduate or postgraduate degree in Pharmacy, Chemistry, or Life Sciences.
Eligible Degrees
B.Pharm, M.Pharm, Pharm.D, B.Sc, M.Sc, B.Chemistry, M.Chemistry, or other relevant graduate/postgraduate qualifications in Chemistry, Pharmacy or Life Sciences.
Relevant regulatory experience is particularly important for this position.
Experience Required
Apotex specifies a minimum of 1 year of experience involving regulatory activities in one or more of the following markets:
- United States (US)
- Canada (CAN)
- European Union (EU)
- Australia/New Zealand (AUS-NZ)
Candidates should ideally understand pre- and post-approval change submissions, new dossier compilation and variation packages.
Skills Required
Relevant skills for the Senior Analyst – PLCM position include:
- Regulatory Affairs
- Product Life Cycle Management
- Regulatory submissions
- New Product Development submissions
- Pre-approval and post-approval changes
- Change-control assessment
- Regulatory documentation
- Dossier compilation
- US and Canadian regulatory requirements
- Regulatory databases and trackers
- SOP and regulatory guideline interpretation
- Cross-functional coordination
How to Apply
