Global Regulatory Strategy Director

Ardelyx, Inc.; San Francisco (CA); On-site; USD 282,000 - 344,000; Full time

Benefits offered by this job

401(k) with employer match

12 weeks paid parental leave

Organ and bone marrow leave

Equity incentive plans

Health plans (medical, prescription, -

Job summary

Ardelyx, Inc. is seeking an Executive Director of Regulatory Affairs to lead global regulatory strategy across the portfolio.

The role partners with Clinical Development, Medical Affairs and Executive Leadership to accelerate development while ensuring compliance with regulatory guidance. You will drive interactions with FDA/EMA, oversee IND/CTA and BLA/NDA/MAA submissions, and mentor a high-performing team.

Qualifications

• Bachelor's degree, advanced degree preferred, in life sciences, pharmacy, chemistry, or related field with 12-15 years of regulatory affairs experience
• Proven track record leading BLA, NDA, or MAA submissions from initiation through approval
• Deep FDA regulations knowledge (21 CFR, ICH) with EMA familiarity
• Experience leading Health Authority meetings and complex regulatory interactions
• Global regulatory experience including ex-US submissions desirable

Responsibilities

• Develop and own global regulatory strategies for pipeline and marketed products, from early development through post-approval lifecycle management
• Serve as primary regulatory strategist on cross-functional development teams, aligning regulatory planning with clinical and commercial objectives
• Provide regulatory intelligence and risk assessment to senior leadership, including Board-level briefings
• Lead interactions with FDA, EMA and other global health authorities, including meetings and Scientific Advice
• Partner with Clinical Development to provide input on trial design, endpoints, and labeling implications
• Review regulatory input on protocols, IBs, CSRs to ensure alignment with strategy
• Lead preparation and execution of IND/CTA submissions and amendments; oversee hold response strategy
• Drive BLA/NDA/MAA submission planning and execution with cross-functional teams
• Oversee preparation and submission of major filings (IND, BLA/NDA, MAA) and post-approval submissions
• Establish submission timelines, resource plans, and readiness frameworks
• Ensure eCTD compliance and submission infrastructure in partnership with Regulatory Operations
• Build, mentor, and retain a high-performing regulatory affairs team
• Monitor FDA/EMA guidances and PDUFA commitments; assess impact and communicate to leadership

Skills

Global regulatory strategy

FDA/EMA expertise

Cross-functional leadership

IND/CTA submissions

BLA/NDA/MAA submissions

Team leadership

Regulatory strategy input

Education

Advanced degree in life sciences

Bachelor's degree

Tools

eCTD submission software

Job description

Ardelyx, Inc. is seeking an Executive Director of Regulatory Affairs to lead global regulatory strategy across the portfolio.

The role partners with Clinical Development, Medical Affairs and Executive Leadership to accelerate development while ensuring compliance with regulatory guidance. You will drive interactions with FDA/EMA, oversee IND/CTA and BLA/NDA/MAA submissions, and mentor a high-performing team.