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) plan with match

Parental leave (12 weeks)

Equity incentive plans

Health plans (medical, dental, vision)

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 leadership to accelerate development while ensuring compliance.

This on-site position sits at our Newark, CA office 2x per week. You will drive regulatory strategies for pipeline and marketed products, oversee IND/CTA and BLA/NDA/MAA submissions, mentor a high-performing team, and stay ahead of FDA/EMA

Qualifications

• Bachelor's degree in life sciences, pharmacy, chemistry, or related field with 12-15 years of regulatory affairs experience.
• Proven track record leading BLA/NDA/MAA submissions from initiation through approval.
• Deep FDA/EMA knowledge with strong agency interaction experience.

Responsibilities

• Develop and own global regulatory strategies for pipeline and marketed products.
• Lead regulatory interactions with FDA/EMA and other authorities, including meetings and submissions.
• Lead IND/CTA submissions, BLA/NDA/MAA planning and execution, and post-approval filings.

Skills

Regulatory strategy leadership

Cross-functional collaboration

FDA/EMA regulatory experience

Team leadership

Strategic planning

Education

Bachelor's degree in life sciences or related

Advanced degree preferred

Tools

eCTD knowledge

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 leadership to accelerate development while ensuring compliance.

This on-site position sits at our Newark, CA office 2x per week. You will drive regulatory strategies for pipeline and marketed products, oversee IND/CTA and BLA/NDA/MAA submissions, mentor a high-performing team, and stay ahead of FDA/EMA