Global Regulatory Strategy Director

Ardelyx, Inc.; Northern (KY); Hybrid; USD 259,000 - 317,000; Full time

Benefits offered by this job

401(k) match

Parental leave

Organ and bone marrow leave

Equity awards

Health plans

Life insurance

Disability insurance

Flexible time off

Holiday pay

Job summary

Ardelyx, Inc. is seeking a Senior Director of Regulatory Affairs to develop and execute global regulatory strategies across the product portfolio. This role partners with Clinical Development, Medical Affairs, and Executive Leadership to accelerate development while ensuring compliance.

The ideal candidate has extensive FDA/EMA experience, deep regulatory expertise, and a proven record of leading BLA/NDA/MAA submissions. Global, cross-functional collaboration is essential.

Qualifications

• 12+ years of regulatory affairs experience in pharma/biotech.
• Led BLA/NDA/MAA submissions from initiation to approval.
• Extensive knowledge of FDA regulations (21 CFR) and EMA guidelines.
• Strong leadership and team development experience.
• Global regulatory strategy across multiple modalities desirable.

Responsibilities

• Develop and own global regulatory strategies for pipeline and marketed products from development to post-approval.
• Serve as primary regulatory strategist on cross-functional development teams.
• Provide regulatory intelligence and risk assessment to senior leadership.
• Lead interactions with FDA, EMA, and other global authorities (Type A/B/C meetings, Scientific Advice).
• Advise on trial design inputs, endpoints, and labeling implications.

Skills

Regulatory affairs

FDA/EMA expertise

Leadership

Cross-functional collaboration

Education

Bachelor's degree in life sciences

Tools

eCTD mastery

Job description

Ardelyx, Inc. is seeking a Senior Director of Regulatory Affairs to develop and execute global regulatory strategies across the product portfolio. This role partners with Clinical Development, Medical Affairs, and Executive Leadership to accelerate development while ensuring compliance.

The ideal candidate has extensive FDA/EMA experience, deep regulatory expertise, and a proven record of leading BLA/NDA/MAA submissions. Global, cross-functional collaboration is essential.