Trainee - Regulatory Affairs

About Apotex Inc.

Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, 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.

For more information visit: www.apotex.com .

Job Summary

• Responsible for the new product submission, deficiency management of Apotex/Co-dev products in US and Canada markets.
• Collation, compilation and submission of regulatory documentation for assigned projects.
• Maintenance of documentation/database records pertaining to products, in line with systems, processes and procedures.
• Supporting and/or coordinating regulatory affairs projects, as assigned.
  
  

Job Responsibilities

• Responsible for the preparation of dossier submission for US/Canada markets to ensure timely approval.
• Responsible for quality eCTD submissions to various Regulatory Authorities within the stipulated and agreed time frame.
• Responsible for the maintenance and timely completion of regulatory documents to support regulatory compliance in various markets.
• Timely communication and follow-up with the respective departments for compilation of regulatory submissions and for database updates.
• Responsible to respond to queries received from Health regulatory agencies on regulatory submissions.
• 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.
• Adherence to the responsibilities as assigned, act as a back-up for team members and support other projects as & when assigned.
• Completion of all the assigned trainings in timely manner.
• Contributes towards the creation and promotion of an environment of teamwork and empowerment built on mutual trust and respect.
• 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
• Masters / bachelor’s degree in pharmacy, Chemistry, or a related Scientific discipline.
• Knowledge, Skills and Abilities
• Knowledge on Global Regulatory Guidance
• Knowledge on Pharma Industry/Products
• Ability to learn and adapt quickly
• Excellent verbal and written communication skills
• Experience
• 0+ years of experience
  

At Apotex, we are committed to fostering a welcoming andaccessible work environment, where all everyone feels valued, respected, and supported to succeed.

We offer 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.

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