Senior Global CMC Regulatory Strategist

3 days ago

Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 18,00,000 - ₹ 24,00,000
Global Regulatory CMC Lead

The role of a Global Regulatory CMC Lead is crucial in ensuring the compliance and success of our products. This position will lead global regulatory strategy, planning, authoring, reviewing, coordination, and submission activities for assigned projects/products.

Main Responsibilities:
  • Develop and implement global CMC regulatory strategies that balance business benefits with regulatory compliance.
  • Plan, author, review, and coordinate global CMC submissions for assigned projects/products.
  • 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.
  • Initiate and lead Health Authority interactions and negotiations as appropriate.
Requirements:
  • Drug product experience is mandatory.
  • Operations Management and Execution.
  • Collaborating across boundaries.
  • Project Management.
  • Change Control.
  • Cross-Functional Teams.
  • Documentation Management.
  • Negotiation Skills.
  • Regulatory Compliance.
  • Risk Assessment.

We value diversity and inclusion at Novartis, and we are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Key qualifications include:

  • Strong communication and project management skills.
  • Ability to collaborate effectively with cross-functional teams.
  • Excellent analytical and problem-solving skills.
  • Knowledge of regulatory requirements and guidelines.
  • Experience with document management systems.

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