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

5 days ago

Mumbai, Maharashtra, India Apotex Full time US$ 80,000 - US$ 1,20,000 per year

ApoPharma, a member of the Apotex group of companies, is a pharmaceutical company devoted to the discovery, development and provision of new medicines to help improve the quality of life of patients with debilitating and life-threatening diseases. Investigation into the pathological role of iron in human disease, and how to use novel medicines to treat conditions created or worsened by iron, is a major research focus of ApoPharma.

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.

At ApoPharma, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.  ApoPharma offers 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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