Senior Regulatory Affairs Specialist

6 days ago

Hyderabad Secunderabad Telangana, India beBeeRegulatory Full time
Job Title: Global Program Regulatory Manager

Key Accountabilities:

  • Develops and implements regulatory strategies for assigned regions, ensuring timely submissions and approvals.
  • Collaborates with regions to align on regulatory strategy, contributing to business objectives - Implements RFP across assigned regions.
  • Identifies requirements and sets objectives for Health Authority (HA) interactions with DRA GPT representative and/or GTAL.
  • Facilitates preparation and finalization of briefing books and contributes to preparation of summary documents.
  • Coordinates responses to HA requests, developing plans for timely response.
  • May serve as local HA liaison depending on location (e.g., FDA or EMA).
  • Drives coordination, planning, and submission of dossiers in assigned regions worldwide.
  • Reviews global dossier summary documents.
  • Develops 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.
  • 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 Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

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