Global Regulatory Strategy Leader

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

Benefits offered by this job

401(k) plan with generous employer 0%?

12 weeks of paid parental leave

Up to 12 weeks of living organ and 0?

Equity incentive plans

Health plans (medical, prescription, 0

Life insurance and disability

Flexible time off

Annual Winter Holiday shut down

At least 11 paid holidays

Job summary

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

This executive partner will drive strategic regulatory decisions with Clinical Development, Medical Affairs, and Leadership to accelerate development while ensuring regulatory compliance. The role requires senior leadership, hands-on experience with IND/CTA and BLA/NDA submissions, and strong interactions with FDA and EMA.

Qualifications

• Bachelor's degree or higher in life sciences, pharmacy, chemistry, or related field with 12-15 years of regulatory affairs experience.
• Proven success leading BLA, NDA, or MAA submissions from initiation through approval.
• Deep expertise in FDA regulations and guidance (21 CFR, ICH), with knowledge of EMA and other frameworks.
• Experience leading Health Authority meetings and managing complex regulatory interactions.
• Experience in clinical regulatory strategy, including protocol design input and endpoint negotiation.
• Strong leadership skills with experience building and mentoring teams.

Responsibilities

• Develop and own global regulatory strategies for pipeline and marketed products across development stages.
• Lead regulatory strategy on cross-functional development teams aligning planning with clinical and commercial goals.
• Provide regulatory intelligence and risk assessment to senior leadership, including Board briefings.
• Lead interactions with FDA, EMA, and other authorities including meetings and scientific advice.
• Contribute to trial design input, endpoints, populations, and labeling implications.
• Oversee preparation of regulatory submissions (IND/CTA, BLA/NDA/MAA) and post-approval filings.

Skills

Regulatory leadership

FDA/EMA expertise

Cross-functional collaboration

Team development

Regulatory strategy

Lifecycle management

Strategic communication

Education

Bachelor's degree in life sciences or related field

Tools

RAC certification (RAPS)

Job description

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

This executive partner will drive strategic regulatory decisions with Clinical Development, Medical Affairs, and Leadership to accelerate development while ensuring regulatory compliance. The role requires senior leadership, hands-on experience with IND/CTA and BLA/NDA submissions, and strong interactions with FDA and EMA.