- Reference: GY44982AO
- Job Type: Permanent
- Location: Limerick
- Category: Science, Pharmaceutical & Food
Summary: This individual will be responsible for researching all CMC aspects of clinical and/or commercial manufacturing and for summarizing the information and data as outlined in regulations and guidance (e.g., ICH guidelines) for CMC documents such as global submissions to regulatory agencies, product quality reviews or other documents, as required.
Essential Duties and Responsibilities include, but are not limited to the following tasks:
• Applies in-depth understanding of regulatory guidance and regulations, as well as industry and government agency best practices and trends, to prepare CMC documents and sections for a variety of biopharmaceutical regulatory submissions, product quality reviews or other documents, as required.
• Researches and utilizes information from existing documents and sources including records, reports, protocols, and project team communications to author submission documents in a uniform style and language for regulatory compliance.
• Collaborates with project teams to manage and coordinate the authoring, review, and finalization of CMC documents in accordance with submission timelines, keeping all stakeholders, including external partners, informed of progress.
• Coordinates the timely and accurate assembly of responses to inquiries from Regulatory agencies on CMC content of regulatory submissions.
• Reviews ancillary CMC documents and reports for completeness and accuracy and for compliance with regulations.
• Identifies project issues and contributes to development of alternate strategies – may contribute to developing CMC regulatory strategy.
Education and Experience Requirements:
• Requires a four year degree in a scientific discipline or equivalent experience with excellent written and verbal communication skills.
• Experience with or knowledge of biopharmaceutical development, testing or manufacturing preferred.
• Strong skills in planning, critical thinking, and problem-solving preferred.
• Ability to work independently, prioritize, coordinate and complete multiple projects within deadline while maintaining a high level of attention to detail is a must for the position.
• Experience in Microsoft® programs (Word, Excel, PowerPoint), Adobe Acrobat, templates and controlled EDMS systems is preferred.
For a confidential discussion and more information on the role/company please email your CV to: email@example.com