Regulatory Affairs Project Manager (Pharmacist)
New
E
ExcelyaRegulatory affairs
Workable workplace: remote; Workable locations: Saclay, Île-de-France, FranceFull-TimeManager
Salary not disclosed
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Job Details
- Languages
- Fluent in English (written and spoken)
- Required Skills
- Project Management
Requirements
- Bring proven experience in global regulatory submissions and regulatory operations.
- Have strong knowledge of eCTD dossier preparation, publishing, and submission processes.
- Have experience with FDA, EMA, China, and Japan regulatory requirements.
- Demonstrate project management and stakeholder coordination skills.
- Manage multiple priorities and meet challenging deadlines.
- Apply risk assessment and problem-solving capabilities.
- Have experience working in cross-functional and international environments.
- Be proactive, organized, and detail-oriented.
- Be fluent in English, written and spoken.
Responsibilities
- Lead global regulatory submission strategies across the FDA, EU, China, and Japan.
- Manage dossier preparation, compilation, and submission activities to meet regulatory requirements and timelines.
- Coordinate external service providers and publishing vendors to support dossier delivery and submissions.
- Identify submission risks, address resource constraints, and support problem-solving to maintain project timelines.
- Drive submission activities across the product lifecycle, from First-in-Human studies through license withdrawal.
- Partner with Global and Regional Regulatory Leads and cross-functional teams on regulatory roadmaps.
- Build and maintain project management tools, submission schedules, dashboards, and milestone tracking.
- Oversee reference dossier preparation for Modules 2–5 and alignment with global and local requirements.
- Monitor submission progress, manage dossier updates, coordinate responses to health authority questions, and maintain regulatory database compliance.
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