job title: Trainee GBS GRA(Apotex)

Roles and Responsibilities

• 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.