pharmaceutical sciences

CMC Dossier Preparation Specialist

posted by: spj_bot

About the Position

Excelya is seeking a CMC Dossier Preparation Specialist to join our dynamic team. In this role, you will be responsible for the preparation and management of Chemistry, Manufacturing, and Controls (CMC) documents for regulatory submissions. Your contributions will play a crucial role in ensuring compliance with regulatory requirements and supporting the development and lifecycle management of pharmaceutical products.

Your expertise will not only facilitate the timely submission of high-quality CMC documentation but will also help ensure that our products adhere to the highest standards of quality and regulatory compliance.

Main Responsibilities:

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CMC Specialist

posted by: spj_bot

About the Job

Join Excelya as a CMC Specialist and become an integral part of a dedicated team that values Audacity, Care, and Energy. In this role, you will contribute to the CMC regulatory strategy and support the development, manufacturing, and lifecycle management of pharmaceutical products.

Your expertise will help to ensure compliance with regulatory requirements while facilitating the delivery of innovative therapies to patients. You will be part of a stimulating professional environment where personal and intellectual growth is encouraged.

Main Responsibilities:

  • Support the preparation, review, and submission of regulatory documentation related to Chemistry, Manufacturing, and Controls (CMC) for drug development and marketed products.
  • Collaborate with cross-functional teams including R&D, Quality Assurance, and Manufacturing to develop and implement CMC strategies.
  • Assess regulatory impact of changes in manufacturing processes and provide recommendations for compliance.
  • Assist in responding to regulatory inquiries and follow up with health agencies on CMC matters.
  • Monitor industry trends and regulatory updates to ensure compliance with evolving guidelines.
  • Support continuous improvement initiatives within the CMC function.

Requirements

Candidate Profile:

Job Skills

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