Manager CMC Regulatory Sciences

  • Reference: GY44497AO
  • Job Type: Permanent
  • Location: Limerick
  • Category: Science, Pharmaceutical & Food

Summary:  Responsible for overseeing information collection, distillation and assessment activities associated with the support functions and preparation of regulatory submissions and Product Quality Reviews, as required.

Essential Duties and Responsibilities include, but are not limited to, the following:
• Managing and developing CMC-RS staff/direct reports.
• Oversees the completion of CMC-RS projects, manages work load and provides direction to CMC-RS Specialists and/or other CMC-RS staff.
• Coordinates or assists with the preparation of a variety of CMC documents.
• Collaborates with project teams to manage and coordinate activities related to the finalization of CMC documents in accordance with established timelines, keeping all stakeholders, including external partners when applicable, informed of progress.
• When applicable, interacts with regulatory authorities from US and international health agencies in support of the CMC modules of regulatory submissions.
• Assists with the timely and accurate assembly of responses to inquiries from Regulatory agencies on the content of CMC documents, when applicable.
• Reviews ancillary CMC documents and reports for completeness and accuracy and for compliance with regulations.
• Identifies project issues and contributes to development of alternate CMC Regulatory Sciences strategies.
• Keeps management informed of decisions, overall strategy and project status.

Education and Experience:
• BS degree in Chemistry, Biology or related field, with at least 8 years of experience working in a technical industry, preferably pharmaceutical or medical device, including some supervisory and/or leadership experience.
• Relevant experience may be substituted for educational requirement.

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Amy O’Neill

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