CMC Regulatory Consultant

7 days ago

Mount, Ireland Procon Est du Canada Ltée Full time

At Procon Est du Canada Ltée, we are committed to excellence in drug development and regulatory affairs. As a Senior Drug Development Specialist, you will play a critical role in ensuring the success of our projects.

About the Company

Our company is a leading provider of clinical research services, with expertise in drug development and regulatory affairs. We are dedicated to delivering high-quality results and exceptional customer service.

We are seeking a highly motivated and experienced professional to join our team as a Senior Drug Development Specialist. In this role, you will be responsible for leading the development and implementation of CMC regulatory strategy plans for combination products / medical devices.

Responsibilities :
  1. Develop and implement CMC regulatory strategy plans for combination products / medical devices.
  2. Work closely with cross-functional teams to execute agreed-upon strategies.
  3. Provide CMC regulatory support for Quality Assurance and quality inspection-ready efforts.
  4. Ensure PM NDA compliance for post approval changes and US / Canada submission.
  5. Prepare CMC documentation to support global regulatory filings.

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