Position Type: Full-time
Location: Dublin, Ireland, Hyrbid.
CMC Submissions: Author and coordinate CMC components for new registrations, post-approval changes, renewals, and annual reports.
Compliance & Quality: Conduct quality reviews of submissions to ensure they meet industry, agency, and format guidelines.
Strategic Support: Contribute to global regulatory strategies and assess regulatory risks for projects across the drug development and manufacturing lifecycle.
Project Management: Track regulatory commitments, manage submission timelines, and maintain data in CMC information systems.
Collaboration: Act as a technical resource for internal stakeholders (R&D, Quality, and Regional Regulatory leads) and coordinate responses to health agency queries.
Technical Expertise: Mandatory hands-on experience in CMC authoring for initial registrations or variations.
Regulatory Knowledge: Strong understanding of cGMPs and global/regional CMC guidelines.
Operational Awareness: Familiarity with pharmaceutical development and manufacturing operations.
Communication: Advanced written and oral communication skills; ability to present complex technical issues for resolution.
Software: Proficiency in Microsoft Office and Documentum-based document management systems.
Integrity: A demonstrated commitment to scientific integrity and regulatory compliance
