Senior Director, Regulatory Strategy, ROW

The Regulatory Affairs (RA) Senior Director, Rest of World (ROW), is responsible for regulatory strategy and execution of submissions in the ROW region, including planning and coordinating complex regulatory submissions such as MAAs and new therapeutic indications. The role also involves representing RA on multidisciplinary teams. ROW is defined as the Vertex International region outside of Europe (EU, UK, and CH).

Key Duties and Responsibilities:

• Acts as the Regulatory ROW Lead managing the international ROW regulatory team, including the submission team at IHQ and affiliate teams in the ROW region.
• Primary accountability for working with regulatory consultants and distributor partners in the ROW region.
• Defines submission strategies and tactics for the ROW region.
• Collaborates with International Regulatory leads and the Global Regulatory Therapy Area Lead (GRTAL) to define ROW regulatory strategies for products and leads or contributes to regulatory and policy discussions with global and cross-functional stakeholders.
• Contributes strategically and tactically to global development plans for assigned drug candidates and other projects.
• Serves as the primary contact for ROW Regulatory Affairs with Vertex International and partners/distributors.
• Works effectively with cross-departmental teams to achieve business goals.
• Ensures projects are prioritized and progressed according to regulatory plans, communicating risks timely.
• Anticipates global regulatory changes in ROW and develops proactive strategies.
• Advises senior management on ROW Regulatory Affairs strategies, procedures, and trends.
• Participates in conferences, regulatory committees, and trade associations to influence the regulatory environment.
• Member of the International Regulatory Affairs Leadership Team.
• May act as Regulatory Regional Lead or Global Regulatory Lead for products.

General:

• Collaborates with cross-department teams, key functions, and partners to meet goals.
• Supervises, coaches, and mentors junior staff and peers, promoting continuous learning.
• Supports process improvement initiatives.
• Exhibits ownership and accountability for projects.
• Willingness to travel to the US and attend ROW meetings.
• Upholds Vertex’s core values.

Knowledge and Skills:

• Experience with regulatory submissions and maintaining approvals across multiple therapeutic areas and modalities, including interactions with stakeholders and authorities.
• Extensive experience in defining and executing ROW regulatory strategies.
• Broad global and cross-functional regulatory knowledge.
• Recognized as a regulatory resource within organizations.

General:

• Passion for innovative biotech work that impacts lives.
• Strong ethics and compliance with industry standards.
• Strategic thinking and understanding of global and local market dynamics.
• Ability to work in a fast-paced, evolving environment.
• Independent yet collaborative work style.
• Proven management, coaching, and mentoring skills.
• Excellent communication and interpersonal skills.
• Fluent in English, both written and spoken.

Other:

• Proactive problem-solving and risk management.
• Accountability in project prioritization and progress.
• Strategic planning for regulatory submissions.
• Adaptability to company growth and change.
• Financial management for submission activities.

Education and Experience:

• Bachelor’s in life sciences required; Master’s or Ph.D. preferred.
• Significant industry experience in regulatory affairs, with supervisory experience.
• Successful track record in complex regulatory submissions.
• Knowledge of regulatory environments and stakeholders in ROW.

Vertex is a global biotech company investing in scientific innovation. Committed to equal opportunity and non-discrimination, with accommodations for disabilities.