Job Description
Principal Scientist Global Regulatory Affairs CMC
Principal Scientist- Global Regulatory Affairs-CMCOur client, a global pharma company, is currently developing a state-of-the-art biotech manufacturing facility based in Limerick (hybrid working) and is 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 organization's portfolio and technical agenda by supporting global clinical trials, 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 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
Interpret new/revised guidance documents and evaluate the 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Provide comments on draft guidance, as applicable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 science discipline (e.g., chemistry, biology, biochemistry, pharmacy, or related scientific discipline) required
Prior Regulatory CMC experience (3-7 years) or an 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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