Global Regulatory 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

Join Excelya, where Audacity, Care and Energy define who we are and how we work. We believe in creating ambitious solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

To strengthen one of our strategic partnerships, we are looking for a Global Regulatory Lead to drive global regulatory strategies and support the development and registration of innovative products worldwide.

Key responsibilities :

• Developing and maintaining global regulatory strategies aligned with development and business objectives.
• Assessing evolving regulatory requirements, competitor landscapes, and regulatory intelligence across major markets.
• Leading interactions with Health Authorities, including EMA, FDA, PMDA, and other key agencies.
• Driving regulatory activities related to registrations, lifecycle management, orphan drug designation, and market expansions.
• Designing and overseeing global submission plans in collaboration with regional regulatory teams and submission management.
• Acting as a core member of global cross-functional project teams, ensuring alignment between Regulatory Affairs, Clinical Development, Safety, CMC, Market Access, and other stakeholders.
• Supporting the preparation and maintenance of CTA/IND documentation, CTD modules, briefing books, regulatory Q&A packages, PIP/PSP activities, and other key regulatory deliverables.
• Leading label development activities and contributing to Company Core Data Sheets (CCDS).
• Managing regulatory risk assessments and maintaining regulatory risk registers.
• Supporting registration activities in key markets and contributing to regulatory due diligence and licensing initiatives when required.
• Evaluating the regulatory impact of quality, efficacy, or safety findings throughout product development.

At Excelya, we encourage taking daring steps, so we seek individuals who are ready to grow with our mission and embody our values.

Education:

Master’s Degree, PharmD, PhD, MD, or equivalent scientific qualification.

Experience:

Advanced experience in Regulatory Affairs with proven expertise in global regulatory strategy, registrations, and lifecycle management within the pharmaceutical or biotechnology industry.

Technical Skills:

Strong knowledge of global regulatory frameworks (ICH, EMA, FDA) and experience supporting product development, submissions, and regulatory interactions with Health Authorities.

Leadership Skills:

Demonstrated ability to lead cross-functional teams, influence stakeholders, and drive strategic decisions in a complex international environment.

Langage : Fluent in English

Why join us?

At Excelya, we combine a passion for science with the enthusiasm of teamwork to redefine excellence in healthcare.

Here’s what makes us unique:

We are a young and ambitious healthcare company, bringing together 900 Excelyates, driven by the goal of becoming the leading mid-sized CRO in Europe, while offering the best employee experience.

Our “one-stop provider” service model—combining full-service, functional service provider, and consulting—allows you to grow through diverse and stimulating projects. By collaborating with leading experts, you will contribute to the development of scientific, operational, and human knowledge, all in service of improving the patient journey.

Excelling with kindness means evolving in an environment that values your natural talents, encourages boldness, pushes boundaries, and cultivates your potential, so that you can fully contribute to our shared mission.