Regulatory Operations Specialist

4 days ago


Hyderabad Warangal Nizamabad, India beBeeRegulatory Full time ₹ 1,00,00,000 - ₹ 1,50,00,000
Job Title: Regulatory Operations Specialist

 

Key Responsibilities:
  • Develop and execute regulatory strategies to manage operational activities across assigned regions.
  • Contribute to the development of the global regulatory strategy, providing input into the Regulatory Functional Plan (RFP) and Seed Document.
  • Collaborate with regional teams to ensure alignment on regulatory strategies and implement RFPs effectively.
  • Determine requirements and set objectives for interactions with Health Authorities (HAs).
  • Facilitate the preparation and finalization of briefing books and contribute to the creation of summary documents.
  • Develop and implement plans for timely responses to HA requests and coordinate responses accordingly.
  • Maintain collaboration with stakeholders and ensure adherence to regulatory compliance standards.

 

Requirements:
  • Minimum 5+ years of experience in Regulatory Affairs is required.
  • The ideal candidate should be able to produce high-quality strategic project documentation and presentations.
  • Deliver reliable, timely, and accurate information about project-specific issues within own department and to key stakeholders.
  • Ability to maintain regulatory documentation following established guidelines and meet regulatory requirements.


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