Regulatory Strategy Director, Renal

Vertex Pharmaceuticals LLC; England; Híbrido; GBP 150.000 - 190.000; Jornada completa

Descripción de la vacante

Vertex Pharmaceuticals LLC in the United Kingdom (Paddington) is seeking a Regulatory Strategy Director for Renal to define and drive regulatory strategies across global programs. This leader will collaborate with Clinical Development, Nonclinical, CMC, Safety, Medical Affairs, and Commercial teams to shape development plans and support business objectives.

The role requires strategic regulatory expertise, strong judgment, and the ability to influence across functions, lead health authority

Formación

• Advanced degree in a scientific, medical, or health-related field is preferred; bachelor’s degree required.
• Significant experience in regulatory affairs within the biopharmaceutical industry.
• Experience with global regulatory strategy for development-stage and/or marketed products.
• Experience in renal, nephrology, rare disease, or specialty therapeutic areas is preferred.

Responsabilidades

• Lead the development and execution of global regulatory strategies for renal therapy programs across all phases of development.
• Serve as the regulatory representative on cross-functional program teams, providing strategic input to development plans and milestone planning.
• Drive regulatory strategy and execution for major submissions, including INDs/CTAs, NDAs, BLAs, MAAs, supplements, variations, and other post-approval filings.
• Lead planning, preparation, and execution of health authority interactions, including meeting strategy and agency responses.
• Provide regulatory guidance on product development, labeling strategy, expedited pathways, pediatric plans, orphan drug designations and regional registration requirements.
• Partner with Regulatory Operations to ensure high-quality, compliant, and timely submissions.

Conocimientos

Regulatory strategy

Cross-functional leadership

Leadership

Communication

Regulatory submissions

Strategic thinking

Educación

Advanced degree

Regulatory affairs experience

Descripción del empleo

Regulatory Strategy Director, Renal
Location: Paddington, United Kingdom
Time Type: Full time
Job Requisition ID: REQ-29466

Job Description

General Summary

The Regulatory Affairs Director will provide global regulatory leadership for programs within the Renal Therapy Team. This role is responsible for defining and driving regulatory strategy for the International region that is aligned with global strategies to support timely advancement of investigational assets. The Director will serve as the regulatory lead on cross-functional teams and will partner closely with Clinical Development, Nonclinical, CMC, Safety, Medical Affairs, Commercial, and Program Leadership to help shape development plans and support business objectives.

This individual will bring strong strategic regulatory expertise, sound judgment, and the ability to navigate complex global regulatory environments. The role requires a collaborative leader who can influence across functions, represent Regulatory Affairs in key governance forums, and lead interactions with health authorities.

Key Responsibilities

• Lead the development and execution of global regulatory strategies for renal therapy programs across all phases of development
• Serve as the regulatory representative on cross-functional program teams, providing strategic input to development plans, evidence generation, and milestone planning.
• Drive regulatory strategy & execution for major submissions, including INDs/CTAs, NDAs, BLAs, MAAs, supplements, variations, and other post-approval filings.
• Lead planning, preparation, and execution of health authority interactions, including meeting strategy, briefing packages, agency responses, and follow-up actions.
• Provide regulatory guidance on product development, labelling strategy, expedited pathways, paediatric plans, orphan drug designations and regional registration requirements.
• Partner with Regulatory Operations and functional subject matter experts to ensure high-quality, compliant, and timely submissions.
• Assess regulatory risks and opportunities and communicate clear recommendations to team leadership and key stakeholders.
• Support lifecycle management activities, including new indications, formulation changes, manufacturing updates.
• Monitor evolving global regulations, guidance, and competitive developments relevant to renal and nephrology programs.
• Contribute to continuous improvement of regulatory processes, standards, and ways of working.
• Mentor and develop other regulatory team members and contribute to a strong, collaborative team culture.

Knowledge and Skills

• Deep understanding of global regulatory requirements and drug development processes across major markets.
• Demonstrated ability to develop and communicate clear, actionable regulatory strategy.
• Strong leadership and influencing skills in a matrixed, cross-functional environment.
• Experience leading complex regulatory submissions and agency interactions.
• Strong written and verbal communication skills, including the ability to present complex regulatory considerations to senior leadership.
• Strong organizational skills and ability to manage multiple priorities with attention to detail.
• Sound judgment, agility, and a proactive, solution-oriented mindset.

Education and Experience

• Advanced degree in a scientific, medical, or health-related field preferred; bachelor’s degree required.
• Typically significant, relevant experience of regulatory affairs within the biopharmaceutical industry.
• Significant experience in global regulatory strategy for development-stage and/or marketed products.
• Experience with renal, nephrology, rare disease, or specialty therapeutic areas preferred.
• Prior experience with US and ex-US regulatory submissions and health authority interactions strongly preferred.

Candidate Profile

The successful candidate will be a strategic and collaborative regulatory leader who is energized by working in a science-driven, patient-focused environment. This person will be comfortable operating in a fast-paced setting, influencing without authority, and helping teams translate complex regulatory requirements into practical development strategies that support innovation and patients with serious diseases.

Flex Designation: Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: Hybrid: work remotely up to two days per week; or select On-Site: work five days per week on-site with ad hoc flexibility.

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.