CMC Regulatory Strategy Lead

14 hours ago

Hyderabad, Telangana, India beBeeregulatory Full time ₹ 1,00,00,000 - ₹ 2,00,00,000

Job Overview:

We are seeking a seasoned Regulatory CMC Manager to lead our global regulatory strategy and ensure compliance with all relevant regulations.

Key Responsibilities:

  • Develop and implement global CMC regulatory strategies, balancing business benefits with regulatory compliance.
  • Lead global CMC submission activities, including planning, authoring, reviewing, coordination, and submission for assigned projects/products.
  • Identify required documentation and content issues for global submissions, ensuring delivery of approved technical source documents within project timelines.
  • Author and/or review high-quality CMC documentation for HA submission, applying agreed-upon CMC global regulatory strategies and current regulatory trends.
  • Maintain technical congruency and regulatory compliance, meeting agreed-upon timelines and e-publishing requirements.

Requirements:

  • Must have experience in drug product development.
  • Strong operations management and execution skills.
  • Able to collaborate across functions.
  • Project management expertise.
  • Familiarity with change control processes.
  • Cross-functional team collaboration skills.
  • Documentation management capabilities.
  • Negotiation and communication skills.
  • Regulatory compliance knowledge.
  • Risk assessment skills.

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