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By making someone else’s life better, you’ll make a real difference in your own.
Lilly unites caring with discovery to make life better for people around the world.
For more than 138 years Lilly has been committed to bringing life-changing medicines to those who need them, advancing the understanding and management of disease, and supporting communities where we live and work.
We’re proud of our heritage, and at our manufacturing site in Kinsale, we value integrity, excellence, and respect for people.
The role holder:
Will oversee the preparation and documentation of specified regulatory submissions
Provide regulatory leadership and direction for products listed as primary responsibilities
Will 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
Will have a good understanding of existing and emerging pharmaceutical & biotech-related regulations
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
Will participate in Lilly’s international Manufacturing Site Regulatory Group to share best practices and develop internal guidelines/initiatives
Will participate, where applicable, in industry association meetings (e.g. PCI) and Lilly groups to benchmark and influence revisions to guidance’s
Will interpret new/revised guidance documents and evaluates impact for site. Provides comments on draft guidance’s, as applicable
Will provide training to site personnel regarding product registration requirements and applicable regulations and guidelines
Minimum of degree, ideally an advanced degree (MS or PhD preferred), in related biological and life science field
5+ years relevant regulatory affairs experience in the pharmaceutical/bio-pharmaceutical industry.
Substantial post-qualification experience in either a pharmaceutical or biotech setting, previous experience with regulatory submissions is an advantage.
Strong knowledge of regulatory and compliance guidelines within pharmaceutical / biopharmaceutical manufacturing.
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, hereby demonstrating a wider business perspective.
Will facilitate a collaborative environment with all internal and external stakeholders.
Stay abreast with current technical and regulatory trends and continually develop knowledge within biopharmaceutical manufacturing by attending training courses, conferences or association meetings and share such information with other members of the group or company to increase their awareness.
Lead and/or contribute corporate improvement efforts at local and international level.
Detail requirement and what we offer
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