Global Regulatory Operations Leader

3 days ago

Hyderabad Secunderabad Telangana, India beBeeRegulatory Full time ₹ 1,50,000 - ₹ 28,00,000
Job Overview","

A Regulatory Manager is responsible for implementing global regulatory strategy and managing operational activities in assigned regions. Key performance indicators include successful implementation of regulatory strategy, identification of main HA issues, successful participation in HA interactions, and adherence to company policy and guidelines.

"," Key Responsibilities:","
  • ","
  • Implement regulatory strategy and manage operational activities in assigned regions.","
  • Provide input into global regulatory strategy and contribute to Regulatory Functional Plan (RFP) and Seed Document.","
  • Partner with regions to align on regulatory strategy and implement RFP across assigned regions.","
  • Determine requirements and set objectives for Health Authority (HA) interactions.","
  • Facilitate preparation and finalization of briefing books and contribute to preparation of 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 in assigned regions worldwide.","
  • Review of 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 representative and/or GTAL.","
  • Responsible for facilitating timely submission and approval of dossier with HAs under the guidance of the representative and/or GTAL.","
  • Erroneous decisions result in critical delays and modifications to projects or operations; cause substantial expenditure of additional time, human resources, and funds; and jeopardize future business activity -Contributes to and often leads the development of departmental goals and objectives.","
  • Reporting of technical complaints / adverse events / special case scenarios related to products within 24 hours of receipt -Distribution of marketing samples (where applicable)","
"," Requirements:","
  • ","
  • Functional Breadth.","
  • Cross Cultural Experience.","
  • Operations Management and Execution.","
  • Project Management.","
  • Clinical Trials.","
  • Detail Oriented.","
  • Drug Development.","
  • Lifesciences.","
  • Negotiation Skills.","
  • Regulatory Compliance.","
  • English.","
","

With a strong focus on regulatory compliance, this role is ideal for individuals with experience in clinical trials, drug development, and lifesciences.

"," "Regulatory Manager"],

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