Global Regulatory Strategy Director

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

Benefits offered by this job

401(k) match

Parental leave 12 weeks

Organ and bone marrow leave up to 12 w

Equity incentives

Health plans (medical, prescription,/d

Life insurance

Disability

Flexible time off

Winter holiday shutdown

11 paid holidays

Job summary

Ardelyx, Inc. in Newark, CA seeks an Executive Director of Regulatory Affairs to design and execute global regulatory strategies across the portfolio.

You will partner with Clinical Development, Medical Affairs, and Executive Leadership to accelerate development while ensuring compliance. You will lead interactions with FDA and EMA, oversee IND/CTA submissions and major filings, and mentor a high-performing regulatory team.

Qualifications

• Bachelor's degree or higher with 12–15 years of regulatory affairs experience in pharma/biotech/medical device
• Proven success leading BLA/NDA/MAA submissions from start to finish
• Strong knowledge of FDA regulations (21 CFR) and ICH guidelines, with EMA familiarity

Responsibilities

• Develop and own global regulatory strategies for pipeline and marketed products, from development through post-approval
• Lead cross-functional development teams and align regulatory planning with clinical and commercial goals
• Provide regulatory intelligence and risk assessments to senior leadership, including Board briefings
• Oversee FDA/EMA interactions, including meetings, scientific advice, and innovative programs
• Guide trial design input, endpoints, and labeling implications in collaboration with Clinical Development
• Review regulatory documents (IBs, CSRs, protocols) to ensure alignment with strategy
• Lead IND/CTA submissions and post-approval filings (BLA/NDA/MAA; CBEs, PASs, supplements)
• Establish timelines, resources, and submission readiness with Regulatory Operations
• Mentor and grow a high-performing regulatory affairs team
• Monitor evolving FDA/EMA guidances and PDUFA commitments, communicating impact to leadership

Skills

Regulatory strategy leadership

FDA regulatory expertise

BLA/NDA/MAA submissions

Cross-functional leadership

Global regulatory affairs

Regulatory risk assessment

Education

Bachelor's degree in life sciences or related field

Job description

Ardelyx, Inc. in Newark, CA seeks an Executive Director of Regulatory Affairs to design and execute global regulatory strategies across the portfolio.

You will partner with Clinical Development, Medical Affairs, and Executive Leadership to accelerate development while ensuring compliance. You will lead interactions with FDA and EMA, oversee IND/CTA submissions and major filings, and mentor a high-performing regulatory team.