Global Regulatory Compliance Manager

1 day ago


Hyderabad Secunderabad Telangana, India beBeeRegulatory Full time ₹ 1,04,000 - ₹ 1,30,878
Job Title

Regulatory CMC Lead Specialist

This role leads and implements all global CMC submission activities for assigned projects/products. It involves formulating and leading global CMC regulatory strategy, maximizing business benefit balanced with regulatory compliance.

Responsibilities:

  • Develop and implement global CMC regulatory strategies to ensure compliance and maximize business benefits.
  • Lead and coordinate all global CMC submission activities, including planning, authoring, reviewing, coordination, and submission.
  • Identify and negotiate the delivery of approved technical source documents in accordance with project timelines.
  • Author and 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.

Requirements:

  • Operations Management and Execution experience.
  • Cross-cultural experience.
  • Project Management skills.
  • Collaborating across boundaries.

Benefits:

  • Delivers reliable, timely, and accurate information/communication about project-specific issues within own department and to key stakeholders.
  • 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.


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