Trainee - Regulatory Affairs

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