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About the Role

The Senior Director, Regulatory Strategy International, is a regulatory leader responsible for overseeing the development and implementation of advanced global regulatory strategies across international markets. This role involves managing teams, shaping cohesive regulatory strategy, and translating regulatory, scientific, operational, and business knowledge into effective implementation plans.

Responsibilities

Leads the development of International regulatory strategy for international markets, including regulatory submission documents and Health Authority communications.
Represents GRA on core development teams and collaborates with regional leaders to ensure unified regulatory input into clinical programs and commercial strategy.
Addresses complex issues, providing advanced regulatory solutions and guidance to cross-functional teams.
Counsels and advises senior management on the status of global Regulatory Affairs strategies and tactics.
Leads the development and management of project plans and timelines, assigning and managing resources effectively.
Influences the regulatory environment through active participation in conferences and industry/agency meetings.
Stays up-to-date on changing regulations, regulatory policy, and intelligence.
Works with cross-department teams to achieve corporate business and department goals.
Leads continuous improvement efforts on existing department processes and strategies.
Leads GRA functional team(s), including skill development, coaching, and performance feedback.
May have financial accountabilities and human resource responsibilities for assigned staff.
Serves as a member of the International Regulatory Affairs Leadership Team.
Exhibits ownership and accountability for all project and internal assignments.
Exemplifies Vertex’s core values in fulfilling job duties.

Requirements

Recent direct experience of regulatory submissions and maintenance of approvals across multiple therapeutic areas and product modalities.
Must include leading direct interactions with a variety of stakeholders including consultants, partners, EMA, and competent national authorities.
Extensive experience of defining and executing International regulatory strategy, including leading policy discussions with a focus on Europe and other International markets.
Ability to apply regulatory knowledge with a broad global and cross-functional mindset.
Demonstrates excellent communication skills with ability to impact and influence team decisions.
Communicates with all levels within the company and acts as liaison/representative internally and externally.
Communicates effectively in verbal presentations and in writing regulatory strategy plans and submission documents.
Able to provide regulatory leadership on a cross-functional team and work effectively in a matrix environment.
Demonstrated technical expertise in regulatory affairs science including advanced knowledge of regulatory frameworks and external environments.
Expert knowledge of global/regional/local regulatory legislation, laws, procedure and guidance for pharmaceutical development of medicines for human use.
Demonstrated knowledge of the research and development, preclinical and clinical requirements related to drug development, registration, and maintenance of human pharmaceuticals.
Empowers other team members through delegation of tasks and decisions.
Excellent communication skills, strong oral/written presentation skills.
Fluent written and spoken English.

Skills

Regulatory strategy
Team management
Global regulatory strategy
Regulatory submissions
Health Authority communications
Project management
Process improvement
Coaching
Performance feedback
Financial accountabilities
Human resource responsibilities
Communication skills
Presentation skills
Technical expertise in regulatory affairs science
Regulatory frameworks
External environments
Regulatory legislation
Drug development
Registration
Maintenance of human pharmaceuticals

Location

International markets (outside North America)

Work Type

Hybrid-Eligible
On-Site Eligible
Hybrid
On-Site

Experience Level

Senior Director
Significant, relevant pharmaceutical or biotech industry experience within regulatory affairs
Extensive supervisory/management experience

Education Level

Bachelor’s degree in life sciences or related discipline
Masters-level or Ph.D. degree is preferred

About the Company

Vertex is a global biotechnology company that invests in scientific innovation.
At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends.
We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.

Equal Opportunity

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.
Vertex is an E-Verify Employer in the United States.
Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com