Regulatory Strategy Director, Renal

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.

• 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.

• 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.

• 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.

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.

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Flex Designation:

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status:

In this…