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Executive Jobs at Apotex | Chemistry Candidates Apply for Global Regulatory Affairs Role
About Apotex:
Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide through a broad portfolio of generic, biosimilar, and innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico, and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.
Job Summary
Responsible for the product life-cycle management of Apotex products in the US and Canada markets. Preparation of submission and approval notifications
for applications submitted to Regulatory agencies (US and Canada). Maintenance of documentation/database records about approved products in line with systems, processes and procedures. Leading and/or coordinating regulatory affairs projects, as assigned.Job Responsibilities
- Responsible for the preparation and review of quality regulatory PLCM submissions 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).
- Responsible for providing support and regulatory guidance to a team in the completion of projects supporting regulatory submissions.
- 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, prepare and review of post-approval supplements to manage the regulatory product life-cycle as applicable.
- Assessment of change control documents. Review of change control forms and provide an accurate assessment for the 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.
- Coordinate with third-party manufacturers for document requirements 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.
- 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 know post-approval change submission requirements and compilation of variation packages for US/CAN/EU/AUS-NZ markets.
Experience: Candidate should have a minimum of 3 years of experience in the US/CAN/EU/AUS-NZ markets
