Trainee, GBS GRA PLCM-GBS-PLC-GBS-PLCM G

Job Summary

• Collation, compilation and dispatch/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 (especially tender projects), as assigned.

Job Responsibilities

• Collation, compilation and timely dispatch of required regulatory documentation to Apotex affiliates/customer and follow-up on timely submission of applications to the health authority.
• Timely communication and follow up with the respective departments for compilation of tender submissions and for database updates.
• Responsible to respond to queries received from Apotex affiliates/customer and health regulatory agencies on regulatory submissions.
• Maintain records in global regulatory databases, update established trackers & status sheets 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: 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 Graduate/ Post graduate in Pharmacy.
• Knowledge, Skills and Abilities:
  • Candidate should have good academic background. Knowledge about New Product Dossier and PLCM submission requirements will be an additional advantage.
• Experience:
  • Should have theoretical understanding of regulatory affairs activities for International/US-CAN-EU markets.