Manages medium to high impact submission projects to ensure timely delivery of high-quality dossiers
Acts as RA Submissions interface with project teams providing guidance and communication
Plans and conducts submission team meetings
Coordinates submission publishing with offsite publishers
May be a technical Subject Matter Expert troubleshooting issues
Facilitates creation of submission content deliverables

🎯 Requirements

Bachelor's degree
4 years pharmaceutical or industry related experience with publishing software tools (e.g.
Experience in Regulatory Affairs preferred (may consider QA, R&D/support, Scientific affairs)
Experience in Regulatory Operations preferred
Proven leadership skills

🎁 Benefits

Comprehensive package of benefits including paid time off (vacation, holidays, sick)
Medical/dental/vision insurance and 401(k) to eligible employees
Long-term incentive programs

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