Global Regulatory Strategy Manager

15 hours ago


Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,50,00,000
Key Accountabilities

As a seasoned regulatory professional, your primary responsibilities will involve developing and implementing global regulatory strategies to ensure timely submissions and approvals. You will collaborate closely with regional teams to align on regulatory approaches and facilitate the submission of dossiers worldwide.

Main Responsibilities:

  • Implement regulatory strategies and manage operational activities for assigned regions.
  • Contribute to the development of global regulatory strategies and create plans for responsive actions to Health Authority (HA) requests.
  • Partner with regions to synchronize regulatory strategies and promote the submission of dossiers globally.
  • Review and approve Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs).
  • Develop and implement strategies to minimize delays during submission review.

Key Performance Indicators:

  • Successful implementation of global regulatory strategies leading to timely submissions and approvals.
  • Identification and resolution of main HA issues through successful participation in regulatory Boards.
  • Adherence to organizational policies and guidelines.

Requirements:

  • Work Experience: Functional Breadth, Cross Cultural Experience, Operations Management, and Project Management.
  • Skills: Clinical Trials, Attention to Detail, Drug Development, Life Sciences, Negotiation Skills, Regulatory Compliance.
  • Languages: English.


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