Principal Scientist- Global Regulatory Affairs-CMC
Our client, a global pharma company, are currently developing a state-of-the-art biotech manufacturing facility based in Limerick (hybrid working) and are currently recruiting for a Principal Scientist- Global Regulatory Affairs-CMC to join their team on a permanent basis. As Principal Scientist- Global Regulatory Affairs-CMC you will provide strategic, tactical and operational direction to expedite the CMC development of the organisations portfolio and technical agenda by supporting global clinical trial, market registration submissions, and post-approval submissions.

Responsibilities:

• Oversee the prepare documentation of 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
• Provides the necessary CM&C commitment information to site personnel
• Ensure compliance of GMP documents to regulatory commitments and provides support for batch release process (review/approval deviations, status of approval of change etc.)
• Review and/or approval of 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’s
• Interpret new/revised guidance documents and evaluate impact for site. Provide comments on draft guidance’s, as applicable
• Provide training to site personnel regarding product registration requirements and applicable regulations and guidelines

• Level 8 Bachelor's degree in sciences discipline (e.g. chemistry, biology, biochemistry or 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