Global Regulatory Specialist

2 days ago


Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,50,00,000
Global Regulatory Manager Job Description

The Global Regulatory Manager is a key role in implementing regulatory strategy and managing operational activities for assigned regions. This position requires the ability to provide input into global regulatory strategy, contribute to Regulatory Functional Plan (RFP), and Seed Document, or their equivalents.

Main Responsibilities:

  • Implementing regulatory strategy and managing operational activities for assigned regions
  • Providing input into global regulatory strategy and contributing to RFP and Seed Document
  • Partnering with regions to align on regulatory strategy to fulfill business objectives
  • Implementing RFP across assigned regions
  • Determining requirements and setting objectives for Health Authority (HA) interactions
  • Facilitating preparation and finalization of briefing books and contributing to preparation of summary documents
  • Developing and implementing plans for timely response to HA requests and coordinating responses
  • Maintaining liaison relationships with HAs as needed
  • Driving coordination, planning, and submission of dossiers in assigned regions worldwide
  • Reviewing global dossier summary documents
  • Developing and implementing plans to avoid/minimize clock stops during submission review
  • Reviewing, approving, and submitting Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs)
  • Reviewing and submitting Risk Management Plans
  • Liaising with regional teams to ensure timely submission and approval of dossiers with HAs

Key Performance Indicators:

  • Successful implementation of global regulatory strategy for timely submissions and approvals
  • Identification of main HA issues
  • Participation in relevant regulatory Boards leading to valuable input from these Boards
  • Successful participation in HA interactions to achieve business objectives

Requirements:

  • Functional breadth
  • Cross-cultural experience
  • Operations management and execution
  • Project management

Skills:

  • Clinical trials
  • Detail-oriented
  • Drug development
  • Lifesciences
  • Negotiation skills
  • Regulatory compliance

Language Skills:

  • English


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