Global Regulatory Lead

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

📋 Description

• Formulate and sustain global regulatory strategies that are in harmony with development and business goals.

• Evaluate changing regulatory requirements, competitive landscapes, and regulatory intelligence across key markets.

• Spearhead communications with Health Authorities, including EMA, FDA, PMDA, and other essential agencies.

• Propel regulatory activities concerning registrations, lifecycle management, orphan drug designation, and market expansions.

• Create and supervise global submission strategies alongside regional regulatory teams and manage submissions.

• Serve as a vital member of global cross-functional project teams.

• Ensure cohesive alignment among Regulatory Affairs, Clinical Development, Safety, CMC, Market Access, and other stakeholders.

• Assist in the preparation and upkeep of CTA/IND documentation, CTD modules, briefing books, regulatory Q&A packages, PIP/PSP activities, and other regulatory outputs.

• Oversee label development processes and contribute to Company Core Data Sheets (CCDS).

• Manage regulatory risk evaluations and uphold regulatory risk registers.

• Facilitate registration efforts in key markets and contribute to regulatory due diligence and licensing activities when necessary.

• Assess the regulatory implications of quality, efficacy, or safety findings throughout the product development cycle.

⛳️ Requirements

• Master's Degree, PharmD, PhD, MD, or an equivalent scientific qualification.

• Extensive experience in Regulatory Affairs.

• Demonstrated proficiency in global regulatory strategy, registrations, and lifecycle management within the pharmaceutical or biotechnology sector.

• In-depth knowledge of global regulatory frameworks, including ICH, EMA, and FDA.

• Experience in supporting product development, submissions, and regulatory interactions with Health Authorities.

• Proven ability to lead cross-functional teams effectively.

• Capacity to influence stakeholders and drive strategic decisions within a complex international context.

• Proficient in English.

🏝️ Benefits

• Opportunity to contribute to the advancement of scientific, operational, and human knowledge.

• Engaging and diverse projects through a comprehensive provider service model.

• Collaboration with leading experts in the field.

• An inclusive environment that values natural talents and personal growth.

• Opportunities for professional development through full-service, functional service provider, and consulting projects.

• A healthcare company culture centered on teamwork.

• A focus on enhancing employee experience.

• An environment that encourages boldness, innovation, and the development of potential.