Regulatory Affairs Scientist
ICDS Recruitment
Cork
Regulatory Affairs Scientist - Cork. Job Responsibilities: • 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 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 provide 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 international Manufacturing Site Regulatory Group to share best practices and develop internal guidelines/initiatives. • Will participate, where applicable, in industry association meetings and groups to benchmark and influence revisions to guidances. • Will interpret new/revised guidance documents and evaluate impact for site. Provides comments on draft guidances, as applicable. • Will provide training to site personnel regarding product registration requirements and applicable regulations and guidelines. Basic Qualifications: 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. Additional Skills/Preferences: • 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, thereby demonstrating a wider business perspective. This job originally appeared on RecruitIreland.com.
2442 days ago