Principal Scientist Global Regulatory Affairs CMC
Principal Scientist- Global Regulatory Affairs-CMC
Our client, a global pharma company, is currently recruiting for a Principal Scientist- Global Regulatory Affairs-CMC for their Cork based manufacturing site. This is a permanent role with hybrid working. As Principal Scientist- Global Regulatory Affairs-CMC, you will provide strategic, tactical and operational direction to expedite the CMC development of the organization's portfolio and technical agenda by supporting global clinical trial, market registration submissions, and post-approval submissions.
Responsibilities:
* Oversee the preparation of documentation for specified regulatory submissions.
* Provide regulatory leadership and direction for products listed as primary responsibilities.
* Develop, plan, and execute appropriate regulatory strategies and priorities through effective partnership with other departments such as TS/MS (process and technology transfer), manufacturing, quality control, and quality assurance.
* Manage submission timelines, monitor approval status, and communicate change status to interested personnel in a timely manner.
* Provide the necessary CM&C commitment information to site personnel.
* Ensure compliance of GMP documents to regulatory commitments and provide support for the batch release process (review/approval deviations, status of approval of change, etc.).
* Review and/or approve regulatory changes, regulatory deviations, proposals for reprocessing, validation, and stability protocols.
* Participate in the Global Regulatory Affairs-CMC group to share best practices and develop internal guidelines/initiatives.
* Participate, where applicable, in industry association meetings & groups to benchmark and influence revisions to guidance.
* Interpret new/revised guidance documents and evaluate impact for the site. Provide comments on draft guidance, as applicable.
* Provide training to site personnel regarding product registration requirements and applicable regulations and guidelines.
Requirements:
* Level 8 Bachelor's degree in a sciences discipline (e.g., chemistry, biology, biochemistry, pharmacy, or related scientific discipline) required.
* Prior Regulatory CMC experience (3-7 years) or equivalent combination of technical and regulatory guidance knowledge and experience preparing regulatory submission content in a technical function.
* Pharmaceutical industry experience in a CMC-related field (5-7 years) will also be considered.
* Strong knowledge of regulatory and compliance guidelines within pharmaceutical/biopharmaceutical manufacturing.
* Good attention to detail and demonstrated effective teamwork skills.
* Proven ability to effectively influence within and beyond the organization.
* Can demonstrate leadership capabilities, particularly with the view to influencing and developing in an international matrix environment.
For more information, please contact Sinéad Cullen on +353879500821 or sinead.cullen@lifescience.ie
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