Senior Analyst, GBS GRA PLCM-GBS-PLCM G

ApoPharma, a member of the Apotex group of companies, is a pharmaceutical company devoted to the discovery, development and provision of new medicines to help improve the quality of life of patients with debilitating and life-threatening diseases. Investigation into the pathological role of iron in human disease, and how to use novel medicines to treat conditions created or worsened by iron, is a major research focus of ApoPharma.

Job Summary

• Responsible for the product life-cycle management of Apotex products (Toronto) 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.
• Assessment in 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: Collaboration, Courage, Perseverance, and Passion.
• 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 Post approval change submission requirement and compilation of variation packages for US/CAN/EU/AUS-NZ/ROW markets.

• Experience:

• Candidate should have minimum 1 year of experience in US/CAN/EU/AUS-NZ/ROW markets.

At ApoPharma, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported. ApoPharma offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.