Senior Manager, Regulatory Affairs and Compliance

2 days ago

Hyderabad Secunderabad Telangana, India beBeeRegulatory Full time

Senior Manager, Regulatory Affairs and Compliance

Job Description:

The role of Senior Manager, Regulatory Affairs and Compliance involves leading global regulatory strategy with a focus on innovation, ensuring business benefit balanced with regulatory compliance. This includes leading and implementing all global CMC submission activities for assigned projects/products.

  • Identify the required documentation and any content, quality and/or timelines issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
  • Author and/or review high-quality CMC documentation for HA submission, applying agreed CMC global regulatory strategies, current regulatory trends and guidelines.
  • Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements.
  • Prepare and communicate CMC Risk Management Assessments, contingency plans, and lessons learned on major submissions and escalate with management as appropriate.
  • Initiate and lead Health Authority interactions and negotiations as appropriate; setting objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans.
  • Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)
Key Performance Indicators:
  • Produces high quality strategic project documentation and presentations; no late changes in strategy due to inadequate prior evaluation.
  • 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 specific issues within own department and to key stakeholders -RA CMC regulatory documentation follows Novartis guidelines and meets regulatory guidelines.
  • Provides high quality regulatory evaluation and strategic advice on time (change control, etc.); regulatory compliance met in all compliance systems.
  • Maintains collaborative partnerships with stakeholders.
Minimum Requirements:Work Experience:
  • Cross Cultural Experience.
  • Operations Management and Execution.
  • Collaborating across boundaries.
  • Project Management.

This role offers opportunities for professional growth and development in a dynamic environment with a dedicated team.

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