Global Regulatory Submissions Project Lead

Ividata Life Sciences; Paris; On-site; EUR 90,000 - 130,000; Full time

Job summary

Jobtailor is seeking a senior Regulatory Affairs lead to drive the global submission plan across the full product lifecycle, align timelines and anticipate risks, and structure the dossier hierarchy for efficient reviews.

You will oversee publishing vendors and coordinate responses to health authority queries, drawing on 10+ years in Regulatory Affairs and fluency in English to ensure robust, timely submissions worldwide.

Qualifications

• Minimum 10 years' experience in project management within a demanding Regulatory Affairs environment.
• Strong knowledge of eCTD dossiers and international submission processes.
• Fluent English.

Responsibilities

• 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

Skills

Regulatory project management

eCTD knowledge

English proficiency

Job description

Jobtailor is seeking a senior Regulatory Affairs lead to drive the global submission plan across the full product lifecycle, align timelines and anticipate risks, and structure the dossier hierarchy for efficient reviews.

You will oversee publishing vendors and coordinate responses to health authority queries, drawing on 10+ years in Regulatory Affairs and fluency in English to ensure robust, timely submissions worldwide.