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Consultant – Regulatory Affairs Project Manager
Ividata Life SciencesProject Manager in Regulatory Affairs for IVIDATA Life Sciences managing global submission plans. Requires 10+ years experience in regulatory affairs project management with fluency in English.
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
project managementeCTD dossiersinternational submission processes
Soft Skills
leadershiprisk managementplanningcoordinationcommunication
Industry Keywords
Regulatory Affairsglobal submission planproduct lifecyclehealth authority queries
About the role
Key responsibilities & impact- Lead the execution of the global submission plan across the entire product lifecycle
- Anticipate operational risks and manage planning and timelines
- Structure the dossier hierarchy and coordinate the collection of documents
- Oversee publishing vendors and coordinate the preparation of responses to health authority queries
Requirements
What you’ll need- Minimum 10 years' experience in project management within a demanding Regulatory Affairs environment
- Strong knowledge of eCTD dossiers and international submission processes
- Fluent English
Benefits
Comp & perks- Stimulating work environment
- Remote work option
- Dynamic team