Assistant Manager, Regulatory Affairs CMC (Global)
$90,000–$120,000 year
On-site · Dublin, Leinster, Ireland
Job Summary
The Assistant Manager, Regulatory Affairs Global CMC will prepare regulatory assessments and contribute to global regulatory strategies for projects related to drug development and manufacturing. Key responsibilities include authoring CMC activities for registrations and changes, coordinating responses to Agency queries, and ensuring high-quality regulatory submissions. The role requires mandatory hands-on CMC authoring experience and a solid understanding of regulatory guidelines. Effective communication skills and the ability to manage regulatory issues while maintaining strong relationships with stakeholders are also essential.
Required Qualifications
- Hands-on CMC authoring experience (initial registrations or post-approval variations)
- Knowledge of development and commercial activities and cGMP's
- Updating, interpreting, and applying global and regional CMC guidelines
- Understanding of global regulatory requirements and expectations
- Advanced skills in written and oral communications
- Computer literacy with Microsoft Office Suite and Documentum-based applications
Desired Qualifications
- Ability to serve as a Subject Matter Expert in specific relevant disciplines
- Demonstrated commitment to scientific and regulatory integrity and quality compliance
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