Global Regulatory Operations Manager

2 days ago


Hyderabad Secunderabad Telangana, India beBeeRegulatory Full time ₹ 1,04,000 - ₹ 13,08,780

Job Summary

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We are seeking a skilled professional to join our team as an Associate Global Program Regulatory Manager. The ideal candidate will have experience in implementing regulatory strategies and managing operational activities.

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Main Accountabilities:

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  • Develop and implement global regulatory strategies for timely submissions and approvals.\
  • Partner with regions to align on regulatory strategy and ensure business objectives are met.\
  • Determine requirements and set objectives for Health Authority interactions.\
  • Facilitate preparation and finalization of briefing books and contribute to summary documents.\
  • Develop and implement plans for timely response to HA requests and coordinate responses.\
  • May serve as local HA liaison depending on location.\
  • Drive coordination, planning, and submission of dossiers worldwide.\
  • Review global dossier summary documents.\
  • Develop and implement plans to avoid/minimize clock stops during submission review.\
  • Reviews, approves and submits Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs).\
  • Reviews and submits Risk Management Plans.\
  • May lead negotiations for regional approvals independently or with DRA GPT representative and/or GTAL.\
  • Responsible for facilitating timely submission and approval of dossier with HAs under the guidance of the DRA GPT representative and/or GTAL.\


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