Vertex Inc.
Regulatory Strategy Director, Renal
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Job Description: Regulatory Affairs Director
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, ensuring alignment with global strategies to support timely advancement of investigational assets.
The Director will serve as the regulatory lead on cross-functional teams and collaborate closely with Clinical Development, Nonclinical, CMC, Safety, Medical Affairs, Commercial, and Program Leadership to 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.
A collaborative leader, this person must 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
- Milestone planning
- Drive regulatory strategy and execution for major submissions, including:
- INDs/CTAs
- NDAs
- BLAs
- MAAs
- Supplements, variations
- Other post-approval filings
- Lead planning, preparation, and execution of interactions with health authorities, including:
- Meeting strategy development
- Briefing package preparation
- Agency response management
- Follow-up actions
- Provide regulatory guidance on:
- Product development
- Labelling strategy
- Expedited pathways
- Paediatric plans
- Orphan drug designations
- Regional registration requirements
- Partner with Regulatory Operations and subject matter experts to ensure high-quality, compliant, and timely submissions.
- Assess regulatory risks and opportunities, communicating clear recommendations to team leadership and stakeholders.
- Support lifecycle management activities, including:
- New indications
- Formulation changes
- Manufacturing updates
- Monitor evolving:
- Global regulations
- Guidance documents
- Competitive developments in renal and nephrology programs.
- Contribute to continuous improvement of regulatory processes, standards, and ways of working.
- Mentor and develop regulatory team members, fostering a collaborative culture.
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Knowledge & Skills
- Deep understanding of:
- Global regulatory requirements
- Drug development processes across major markets
- Demonstrated ability to develop and communicate clear, actionable regulatory strategy.
- Strong leadership and influencing skills in matrixed, cross-functional environments.
- Experience leading complex regulatory submissions and agency interactions.
- Excellent written and verbal communication skills, including presentation of intricate regulatory considerations to senior leadership.
- Strong organizational skills with attention to detail, effectively managing multiple priorities.
- Sound judgment, agility, and a proactive, solution-oriented mindset.
Education & Experience
- Preferred: Advanced degree in a scientific, medical, or health-related field.
- Required: Bachelor’s degree in a relevant discipline.
- Experience:
- Significant, relevant experience in Regulatory Affairs within the biopharmaceutical industry.
- Significant experience with global regulatory strategy for development-stage and/or marketed products.
- Preferred: Experience in renal, nephrology, rare disease, or specialty therapeutic areas.
- Preferred: Prior experience with US and ex-US regulatory submissions and agency interactions.
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Candidate Profile
The successful candidate will be a strategic and collaborative regulatory leader, thriving in a science-driven, patient-focused environment. This person will:
- Comfortably operate in a fast-paced setting.
- Influence without formal authority.
- Help teams translate complex regulatory requirements into actionable strategies supporting medicinal innovation and treating serious diseases.
Designation: Hybrid-Eligible or On-Site Eligible
- Hybrid: Option to work remotely up to two days per week.
- On-Site: Option to work five days per week on-site, with ad hoc flexibility.
Note: Flex eligibility is subject to Vertex’s Policy on Flex @ Vertex Program and may be revised at any time.
Vertex is a global biotechnology company committed to scientific innovation, creating transformative therapies for serious diseases. Vertex prioritizes diversity and inclusion, celebrating diverse perspectives to drive innovation and improve patient lives.
For more information: www.vrtx.com | LinkedIn
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