Regulatory Activities Coordinator

3 days ago

Hyderabad Secunderabad Telangana, India beBeeRegulatory Full time ₹ 9,00,000 - ₹ 12,00,000
Regulatory Activities Coordinator Job Description

Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation and publication of CMC documentation for submissions to Health Authorities.

Major accountabilities include:

  • Authoring high-quality global CMC documentation for Health Authority submission throughout the product lifecycle, applying agreed CMC global regulatory strategies, current regulatory trends, and guidelines.
  • Ensuring technical congruency and regulatory compliance, meeting agreed-upon timelines and e-publishing requirements.
  • Identifying required documentation and content, quality, and timeliness issues for global submissions and negotiating the delivery of approved technical source documents in accordance with project timelines.
  • Coordinating and collecting source documentation needed for direct submission to Health Authorities as needed.
  • Actively participating as a member of the global RA CMC team by contributing to the regulatory strategy, identifying critical issues, and lessons learned.
  • Performing support activities for the overall department such as data entry into the Regulatory Information Management System, other CMC database entry, or maintenance and operational activities as needed.
  • Reporting technical complaints, adverse events, or special case scenarios related to Novartis products within 24 hours of receipt – distributing marketing samples where applicable.
Key Performance Indicators
  • Produces high-quality regulatory documentation.
  • No delays in approvals of clinical studies, global registration dossiers, or variations due to late or inadequate submission documentation on matters within RA CMC control.
  • Delivers reliable, timely, and accurate information/communication about project documentation specific issues within their own department and key stakeholders.
  • RA CMC regulatory documentation follows Novartis guidelines and meets regulatory guidelines.
  • Builds and maintains collaborative partnerships with stakeholders.
Required Skills and Qualifications
  • Documentation Management.
  • Lifesciences.
  • Operational Excellence.
  • Regulatory Compliance.

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