Global Regulatory Lead

Excelya

1d

About The Position

Excelya is seeking a Global Regulatory Lead to support a strategic partnership and drive global regulatory strategies for the development and registration of innovative products worldwide. The role involves working across major markets and with global, regional, and cross-functional teams to support product development, submissions, registrations, and lifecycle management.

Requirements

• Master's degree, PharmD, PhD, MD, or equivalent scientific qualification.
• Advanced experience in Regulatory Affairs, with proven expertise in global regulatory strategy, registrations, and lifecycle management within the pharmaceutical or biotechnology industry.
• Strong knowledge of global regulatory frameworks, including ICH, EMA, and FDA.
• Experience supporting product development, submissions, and regulatory interactions with Health Authorities.
• Demonstrated ability to lead cross-functional teams, influence stakeholders, and drive strategic decisions in a complex international environment.
• Fluent in English.

Responsibilities

• Develop and maintain global regulatory strategies aligned with development and business objectives.
• Assess evolving regulatory requirements, competitor landscapes, and regulatory intelligence across major markets.
• Lead interactions with Health Authorities, including EMA, FDA, PMDA, and other key agencies.
• Drive regulatory activities related to registrations, lifecycle management, orphan drug designation, and market expansions.
• Design and oversee global submission plans in collaboration with regional regulatory teams and submission management.
• Serve as a core member of global cross-functional project teams, aligning Regulatory Affairs with Clinical Development, Safety, CMC, Market Access, and other stakeholders.
• Support preparation and maintenance of CTA/IND documentation, CTD modules, briefing books, regulatory Q&A packages, PIP/PSP activities, and other regulatory deliverables.
• Lead label development activities and contribute to Company Core Data Sheets (CCDS).
• Manage regulatory risk assessments and maintain regulatory risk registers.
• Support registration activities in key markets and contribute to regulatory due diligence and licensing initiatives when required.
• Evaluate the regulatory impact of quality, efficacy, or safety findings throughout product development.

Benefits

• Opportunities to grow through diverse and stimulating projects across full-service, functional service provider, and consulting offerings.
• Collaboration with leading experts and opportunities to contribute to scientific, operational, and human knowledge.
• An environment that values natural talents, encourages boldness, pushes boundaries, and cultivates employee potential.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior