Manager, Regulatory Affairs CMC
$140,000–$160,000 year
Remote · United States
Job Summary
Manager, Regulatory Affairs CMC oversees planning, compilation, QC, and submission of INDs, BLAs, and amendments; prepares routine IND and CTA amendments; collaborates with submission authors/reviewers to ensure source document planning and high-quality submissions; provides regulatory expertise to cross-functional teams; interfaces with QA and manufacturing to maintain robust change control; develops CMC regulatory strategy for product changes; negotiates with internal stakeholders to align with ICH guidelines and country regulations; participates in risk mitigation and maintains submission logs; assists in managing project trackers and Gantt charts; works in a professional or remote office environment; requires BA/BS and 8+ years of experience; salary range $140k-$160k; LI-remote.
Required Qualifications
- BA/BS degree in related field required
- At least 8 years’ experience in regulatory affairs or a related function in drug/biologic development
- Experience in managing regulatory submissions for investigational or marketed products to global health authorities in eCTD format
- Broad understanding of international regulations and procedures in drug/biologics development; familiarity with ICH and regional regulatory requirements
- Organizational and planning skills; ability to influence and negotiate professionally at various levels within the project team and with external partners while maintaining positive working relationships
- Advanced skills in using Microsoft Office Suite (Word, PowerPoint, and Excel) and Adobe Acrobat Pro
- High attention to detail and accuracy
- Excellent interpersonal, verbal and written communication skills
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
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