Regulatory Affairs Project Manager

This is a fully remote position, open to applicants in France.

📋 Description

• Lead the development, coordination, and implementation of global regulatory submission strategies for markets including FDA, EU, China, and Japan.

• Oversee the preparation, compilation, and submission of dossiers while ensuring adherence to regulatory standards and timelines.

• Collaborate with external service providers and publishing vendors to ensure timely dossier delivery and submissions.

• Identify potential submission risks, tackle resource limitations, and facilitate problem-solving to uphold project timelines.

• Manage regulatory submission processes throughout the entire product lifecycle, from First-in-Human studies to license withdrawal.

• Partner with Global and Regional Regulatory Leads and cross-functional teams to develop global regulatory roadmaps.

• Create and maintain project management tools, submission timelines, dashboards, and milestone tracking systems.

• Supervise the preparation of reference dossiers (Modules 2-5) in accordance with both global and local standards.

• Track submission progress, manage dossier updates, coordinate responses to inquiries from health authorities, and ensure compliance with regulatory databases.

• Collaborate effectively with teams in Medical Writing, Clinical Development, R&D Operations, Technical Management, and external industry stakeholders.

⛳️ Requirements

• Demonstrated experience in global regulatory submissions and regulatory operations.

• In-depth knowledge of eCTD dossier preparation, publishing, and submission methodologies.

• Familiarity with regulatory requirements in FDA, EMA, China, and Japan.

• Strong project management abilities and skills in stakeholder coordination.

• Capability to handle multiple priorities and meet demanding deadlines.

• Proficient in risk assessment and problem-solving techniques.

• Experience in cross-functional and international working environments.

• A proactive, organized, and detail-oriented approach.

• Exceptional communication and collaboration skills.

• Fluent in English, both written and spoken.

🏝️ Benefits

• Diverse projects available through a comprehensive service model that includes full-service, functional service provider, and consulting options.

• Opportunity to collaborate with leading experts in the industry.

• A work environment that embraces natural talents, encourages audacity, and fosters professional growth.

• Focus on providing the best employee experience.

• Chance to contribute to enhancing scientific, operational, and human knowledge to improve patient journeys.