Apotex Inc Hiring Analyst for Chemistry, Pharmacy & Life Sciences Graduates

Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally.

Post : Analyst, GBS GRA PLCM-GBS-PLCM G

Job Description
Job Summary
• Responsible for the product life-cycle management of Apotex products in identified markets.
• Maintenance of documentation/database records pertaining to approved products in line with systems, processes and procedures.
• Preparation of submission and approval notifications for applications submitted to Regulatory agencies.

Job Responsibilities
• Responsible for the preparation of quality post-launch PLCM packages for various markets to ensure timely approval.
• Responsible for the maintenance and timely completion of regulatory documents to support regulatory compliance in various markets.
• Accountable for assessment, coordination and compilation of deficiency responses in a timely manner.
• Works with other functional areas to resolve issues related to information for regulatory submissions.
• Evaluate and prepare post-approval supplements to manage the regulatory product life-cycle as applicable.
• Assist review of change control documents. Review of change control forms and provide accurate assessment for change being assessed (as applicable and assigned).
• Maintenance of regulatory databases to ensure accuracy of information. Maintain established trackers (Review checklist for PLCM/deficiency response, deficiency tracker, submission spreadsheet etc.) and ensure accuracy of information.
• Co-ordinate with third party manufacturers for document requirement for regulatory submissions.
• Act as a back-up for team members and support as & when required.
• Timely communication and follow-up with the respective departments for compilation and submission of PLCM submissions and query responses to meet agreed timeline.
• Interpret and ensure compliance with SOPs, RA policies & procedures and regulatory guidelines. Prepare and/or draft SOPs and regulatory guidelines (as applicable).
• Interact with other applicable departments within Apotex to discuss and provide solutions to regulatory issues and/or problems.
• Communicate with external sources such as agents and suppliers to request and/or provide data relevant to submissions.
• Seeks guidance from other team members to enhance regulatory knowledge.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Integrity, Teamwork, Courage, and Innovation.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.

Candidate Profile
• A Post-graduate/Graduate degree in Chemistry/ Pharmacy/ Life Sciences or other(s).
• Candidate should have understanding of various departments in pharmaceutical company.
• Candidate should have understanding of activities performed by regulatory affairs department and various softwares systems used by regulatory professionals.
• Candidate should have minimum 1 year of experience in handling various systems used by regulatory professionals.

Additional Information
Experience : minimum 1 year
Qualification : Post-graduate/Graduate degree in Chemistry/ Pharmacy/ Life Sciences
Location : Mumbai, MH, IN
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : GBS GRA PLCM-GBS-PLCM G
End Date : 28th February 2026