Executive Director, Regulatory Affairs

About the role

Ardelyx, a commercial-stage biopharmaceutical company, is hiring an Executive Director of Regulatory Affairs in Newark, California. The role develops and executes global regulatory strategy across the product portfolio and acts as a strategic partner to Clinical Development, Medical Affairs and Executive Leadership, ensuring full compliance with applicable regulations.

Key responsibilities

• Own global regulatory strategies for pipeline and marketed products, from early development through post-approval lifecycle management
• Serve as the primary regulatory strategist on cross-functional development teams, aligning regulatory planning with clinical and commercial objectives
• Provide regulatory intelligence and proactive risk assessment to senior leadership, including Board-level briefings
• Lead interactions with the FDA (CDER/CBER/CDRH), EMA and other health authorities, including Type A/B/C meetings, Scientific Advice and Innovation Office engagements
• Advise Clinical Development on early-stage and registration-enabling trials, including endpoints, patient populations, statistical analysis plans and labeling
• Review protocols, IBs, CSRs and other clinical documents, and lead IND/CTA submissions and amendments, including clinical hold responses
• Plan and execute BLA/NDA/MAA submissions, authoring and reviewing Module 2 summaries and managing submission teams
• Oversee major regulatory filings and post-approval submissions (CBEs, PASs, supplements, annual reports), set submission timelines and ensure eCTD compliance
• Build, mentor and retain a regulatory affairs team, and monitor new FDA/EMA guidances, PDUFA commitments and international regulatory developments

Required profile

• Bachelor's degree, advanced degree preferred, in life sciences, pharmacy, chemistry or a related field, with 12-15 years of regulatory affairs experience in pharma, biotech or medical devices, or equivalent
• Demonstrated success leading BLA, NDA or MAA submissions from initiation through approval
• Proven track record of leading Health Authority meetings and managing complex regulatory interactions
• Experience in clinical regulatory strategy, including protocol design input, trial design and endpoint negotiation with agencies
• Strong leadership skills and experience managing and developing regulatory teams
• RAC certification (RAPS) is a plus; experience across therapeutic areas, global regulatory work and expedited designation programs is desirable

Required skills

• Deep expertise in FDA regulations and guidance (21 CFR, ICH guidelines)
• Strong working knowledge of EMA and other major regulatory frameworks

What we offer

• Anticipated annualized base pay of $282,000 - $344,000, with possible annual bonus target and equity awards
• 401(k) with generous employer match, 12 weeks of paid parental leave, equity incentive plans
• Health, dental, vision, life insurance and disability coverage
• Flexible time off, annual Winter Holiday shut down and at least 11 paid holidays