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  • 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/customers 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 for responding to queries received from Apotex affiliates/customers and health regulatory agencies on regulatory submissions.
  • Maintain records in global regulatory databases, update established trackers & status sheets, and ensure the 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 training in a 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 Behaviors that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
  • Ensure personal adherence to 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.

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