CMC Assistant Manager

Role Overview: Assistant Manager, Regulatory Affairs (Global CMC)

Position Type: Full-time

Location: Dublin, Ireland, Hyrbid.

Core Responsibilities

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CMC Submissions: Author and coordinate CMC components for new registrations, post-approval changes, renewals, and annual reports.
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Compliance & Quality: Conduct quality reviews of submissions to ensure they meet industry, agency, and format guidelines.
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Strategic Support: Contribute to global regulatory strategies and assess regulatory risks for projects across the drug development and manufacturing lifecycle.
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Project Management: Track regulatory commitments, manage submission timelines, and maintain data in CMC information systems.
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Collaboration: Act as a technical resource for internal stakeholders (R&D, Quality, and Regional Regulatory leads) and coordinate responses to health agency queries.

Required Skills & Experience

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Technical Expertise: Mandatory hands-on experience in CMC authoring for initial registrations or variations.
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Regulatory Knowledge: Strong understanding of cGMPs and global/regional CMC guidelines.
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Operational Awareness: Familiarity with pharmaceutical development and manufacturing operations.
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Communication: Advanced written and oral communication skills; ability to present complex technical issues for resolution.
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Software: Proficiency in Microsoft Office and Documentum-based document management systems.
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Integrity: A demonstrated commitment to scientific integrity and regulatory compliance