Global Regulatory Strategy Lead

Excelya; United States; Remote; USD 180,000 - 260,000; Full time

Job summary

Excelya is seeking a Global Regulatory Lead to drive regulatory strategy, registrations, and lifecycle management for innovative products worldwide. You will lead interactions with Health Authorities and coordinate with Regulatory Affairs, Clinical Development, Safety, CMC, and Market Access.

The ideal candidate holds a Master’s degree or higher in a scientific field and has extensive experience in global regulatory strategy within pharma/biotech, including submissions and lifecycle management.

Qualifications

• Advanced experience in Regulatory Affairs with global strategy and lifecycle management.
• Experience leading regulatory submissions and interactions with Health Authorities.
• Strong knowledge of global regulatory frameworks (ICH, EMA, FDA).
• Proven ability to lead cross-functional teams in an international environment.

Responsibilities

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

Skills

Regulatory strategy

Regulatory submissions

Health Authority interactions

Lifecycle management

Education

Master’s degree, PharmD, PhD, MD or equivalent

Job description

Excelya is seeking a Global Regulatory Lead to drive regulatory strategy, registrations, and lifecycle management for innovative products worldwide. You will lead interactions with Health Authorities and coordinate with Regulatory Affairs, Clinical Development, Safety, CMC, and Market Access.

The ideal candidate holds a Master’s degree or higher in a scientific field and has extensive experience in global regulatory strategy within pharma/biotech, including submissions and lifecycle management.