Job Description

Hlx is partnering with an innovative, early-stage biotech developing novel therapies for rare renal diseases. As the company transitions into Phase II clinical development, we are seeking a Vice President of Regulatory Affairs & Quality Assurance to lead global regulatory strategy and guide the organisation through its next phase of growth.

This is a pivotal leadership role, with primary responsibility for defining and executing regulatory strategy across key markets. The successful candidate will act as the company’s regulatory authority, ensuring alignment with global health agencies while enabling efficient and compliant clinical progression.

Responsibilities

• Define and lead the global regulatory strategy across the US, EU, and other relevant territories
• Serve as the primary point of contact with regulatory authorities, including FDA, EMA, and MHRA
• Lead preparation, submission, and maintenance of INDs, CTAs, and regulatory briefing documents
• Provide regulatory leadership for Phase II trial design and execution, ensuring alignment with agency expectations
• Drive regulatory interactions, including scientific advice meetings, pre-IND/End-of-Phase meetings, and orphan designation applications
• Advise executive leadership and Board on regulatory risks, timelines, and opportunities

Regulatory Operations & Leadership

• Build and implement scalable regulatory processes appropriate for a growing biotech
• Oversee regulatory documentation, timelines, and submission planning
• Partner cross-functionally with Clinical, CMC, and external vendors to ensure regulatory alignment

Quality Assurance Oversight - working with QA group / CRO

• Establish and maintain a fit-for-purpose Quality Management System (QMS)
• Ensure compliance with GxP standards across clinical and CMC activities
• Oversee audit and inspection readiness, including management of external vendors (CROs/CDMOs)

Qualifications

• Extensive experience in Regulatory Affairs within biotech or pharmaceutical environments
• Proven track record supporting clinical development (Phase II & III), ideally within rare disease or orphan indications
• Deep understanding of global regulatory frameworks, particularly FDA and EMA pathways
• Experience leading direct interactions with Health Authorities and managing key regulatory milestones
• Working knowledge of Quality Assurance and GxP compliance in a clinical-stage setting
• Prior exposure to renal or nephrology indications is advantageous
• PhD

If interested, please email george.pyett@hlxlifesciences.com

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