Intelligence Specialist – Regulatory Affairs

2 weeks ago

Hyderabad Secunderabad Telangana, India beBeeRegulator Full time

Job Summary

This is a senior-level position responsible for leading intelligence gathering and analysis within the regulatory affairs function.

  • Key Responsibilities:
  • Monitor and analyze global regulatory landscapes to provide actionable insights and inform filing strategies.
  • Compile and synthesize regulatory requirements from local affiliates, ensuring outputs are clear and aligned with business needs.
  • Prepare deliverables such as monitoring reports, bulletins, and landscape summaries.
  • Manage regulatory intelligence tools, databases, and repositories, ensuring they are up-to-date and accessible to stakeholders.
  • Collaborate with cross-functional teams to provide timely data and regulatory insights for product strategy discussions.
  • Track progress against intelligence gathering plans and timelines, reporting regularly on task status and potential bottlenecks.

Required Skills and Qualifications

Regulatory Knowledge:

  • Strong understanding of regulatory affairs principles, global submission processes, and regional regulatory requirements.
  • Able to interpret health authority guidance and summarize critical impacts.
  • Awareness of how regulatory changes affect product lifecycle and submissions.

Attention to Detail and Analytical Skills:

  • Strong data analysis and synthesis abilities.
  • Accuracy in interpreting and entering regulatory data.
  • Ability to identify key changes, trends, and propose relevant insights.

Technical and Project Skills:

  • Proficiency with regulatory intelligence databases and information systems.
  • Ability to configure or optimize internal tools such as SharePoint, dashboards, or custom trackers.
  • Good project coordination skills with the ability to manage multiple workstreams.
  • Strong communication skills, both written and verbal, for effective reporting and collaboration.

Benefits

Competitive salary, comprehensive benefits package, and opportunities for professional growth and development.

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