Senior Director, Intl Regulatory Affairs Geo-Expansion

Job Description

General Summary:

The Senior Director, Regulatory Strategy International, is a regulatory leader with expert technical and tactical experience in regulatory strategy who will be responsible for overseeing the development and implementation of advanced global regulatory strategies across international markets (those outside North America, which includes the European Affiliates (EU, UK, and CH) and Rest of World (ROW)). This includes (1) development programs in emerging disease areas, (2) additional development of registered Vertex medicines, and/or (3) support of Vertex marketed products. The incumbent is responsible for team management and will play a major role in shaping cohesive regulatory strategy across assigned programs, ensuring effective integration of broad regulatory ideas/tactics supporting franchise strategy. This role will understand and translate regulatory, scientific, operational and business knowledge into effective implementation plans and strategy.

Key Duties and Responsibilities:

• Leads the development of International regulatory strategy for international markets, which may include multiple and/or complex projects at different stages of development (from first-in-human to post marketing application stage) outlined in Global Regulatory Strategy Documents including regulatory submission documents and Health Authority communications
• Represents GRA on core development teams, project teams, and collaborate with regional leaders and teams to ensure unified regulatory input into clinical programs and commercial strategy, as required
• Addresses complex issues, providing advanced regulatory solutions and guidance to cross- functional teams and align communication to and from cross-functional teams and GRA leadership. Counsels and advises senior management on status of global Regulatory Affairs strategies and tactics, procedures and practices.
• Leads the development and management of project plans and timelines and assigns and manages resources effectively to ensure all projects are appropriately prioritized and key goals are met on time
• Works to influence regulatory environment through active participation in conferences and industry/agency regulatory meeting, committees and trade associations. Remains up to date on changing regulations, and regulatory policy and intelligence including competitive issues that influence regulatory strategy.
• Effectively working with cross-department teams (e.g., submission and launch teams, within Regulatory, etc.) leaders to achieve corporate business and department goals and objectives
• Leads continuous improvement efforts on existing department processes and strategies - for example aligning on new & more efficient ways of working, mapping processes, creating new business documents (e.g., new SOPs)
• Leads GRA functional team(s) including participating in the skill development, coaching, and performance feedback for members of the GRA functional teams
• As a people manager within the International GRA organization, may have financial accountabilities and human resource responsibilities for assigned staff
• Member of the International Regulatory Affairs Leadership Team
• Exhibit ownership and accountability for all project and internal assignments
• Exemplify Vertex’s core values in fulfilling these job duties

Knowledge and Skills:

• 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 essential
• Demonstrates excellent communication skills with ability to impact and influence the decisions of a team, communicates with all levels within the company and acts as liaison / representative both internally and externally and 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, with 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

Education and Experience:

• Bachelor’s degree in life sciences or related discipline required; Masters-level or Ph.D. degree is preferred
• Typically requires significant, relevant pharmaceutical or biotech industry experience within regulatory affairs and extensive supervisory/management experience, or the equivalent combination of education and experience

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.

Flex Designation:

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:

1. Hybrid: work remotely up to two days per week; or select

2. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Hybrid

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

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 [email protected]