Senior Analyst - Product Life Cycle Management

Job Summary

• Support in preparation of new product submissions and responsible for product life-cycle management of Apotex products in US and Canada markets.
• Preparation of submission and approval notifications for applications submitted to Regulatory agencies (US and Canada)
• Maintenance of documentation/database records pertaining to approved products in line with systems, processes and procedures.

Job Responsibilities

• Responsible for the preparation and review of quality regulatory PLCM submissions for various markets (US and Canada) to ensure timely approval.
• Support in preparation of NPD submission for various markets (US and Canada) to ensure timely approval.
• Responsible for the maintenance and timely completion of regulatory documents to support regulatory compliance in various markets (US and Canada).
• Prepare pre and post-approval supplements to manage the regulatory product life-cycle as applicable.
• Assessment 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 NPD/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 and 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.
• 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.

Job Requirements

• Education: A Post-graduate/Graduate degree in Chemistry/ Pharmacy/ Life Sciences.
• Knowledge, Skills and Abilities: Candidate should have knowledge about pre and post-approval change submission requirement and compilation of new dossier/variation packages for US/CAN/EU/AUS-NZ markets.
• Experience: Candidate should have minimum 1 years of experience in US/CAN/EU/AUS-NZ markets.

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