Global Regulatory Strategy Director

Ardelyx, Inc.; Newark (CA); On-site; USD 259,000 - 317,000; Full time

Benefits offered by this job

401(k) match

Parental leave

Organ & marrow leave

Equity awards

Health plans

Life insurance

Disability insurance

Flexible time off

Winter holiday shutdown

Holidays

Job summary

Ardelyx, Inc. is seeking a Senior Director of Regulatory Affairs to lead global regulatory strategy across the portfolio, partnering with Clinical Development, Medical Affairs and Executive Leadership to accelerate development while ensuring compliance.

The role oversees IND/CTA submissions, BLA/NDA/MAA planning, and interactions with FDA/EMA and other authorities, with a focus on building and retaining a high-performing regulatory team.

Qualifications

• Bachelor's degree in life sciences or related field; 12+ years in regulatory affairs.
• Proven success leading BLA/NDA/MAA submissions.
• Deep FDA/EMA knowledge and cross-agency experience.

Responsibilities

• Develop and own global regulatory strategies from development to post-approval.
• Lead cross-functional development teams to align regulatory planning with clinical and commercial goals.
• Lead FDA/EMA interactions including meetings and scientific advice.
• Guide IND/CTA submissions and post-approval filings (NDA/BLA/MAA).
• Mentor regulatory team and monitor evolving guidelines.

Skills

Regulatory strategy

Leadership

Cross-functional leadership

Global regulatory experience

Regulatory submissions

Education

Bachelor's degree

Advanced degree preferred

RAC certification (nice to have)

Job description

Ardelyx, Inc. is seeking a Senior Director of Regulatory Affairs to lead global regulatory strategy across the portfolio, partnering with Clinical Development, Medical Affairs and Executive Leadership to accelerate development while ensuring compliance.

The role oversees IND/CTA submissions, BLA/NDA/MAA planning, and interactions with FDA/EMA and other authorities, with a focus on building and retaining a high-performing regulatory team.