Global Regulatory Strategy Director

Ardelyx; Waltham (MA); On-site; USD 259,000 - 317,000; Full time

Benefits offered by this job

401(k) plan with employer match

Paid parental leave

Health plans (medical, prescription, …

Life insurance and disability

Equity awards

Job summary

Ardelyx is seeking a Senior Director of Regulatory Affairs to drive global regulatory strategy across the product portfolio. You will partner with Clinical Development, Medical Affairs, and Executive Leadership to accelerate development while ensuring full compliance with regulations.

You will lead interactions with FDA/EMA, oversee IND/CTA and BLA/NDA/MAA submissions, and mentor a high-performing regulatory team.

Qualifications

• Bachelor's degree with 12+ years of regulatory affairs experience in pharma/biotech.
• Demonstrated success leading BLA/NDA/MAA submissions from start to approval.
• Deep expertise in FDA regulations (21 CFR) and ICH guidelines.
• Proven record of Health Authority meetings and complex regulatory interactions.
• Experience in clinical regulatory strategy including protocol design input.
• Strong leadership and people development skills.
• RAC certification is a plus.

Responsibilities

• Develop and own global regulatory strategies for pipeline and marketed products.
• Lead cross-functional development teams and align regulatory planning with clinical objectives.
• Provide regulatory intelligence and risk assessment to senior leadership.
• Lead interactions with FDA/EMA and other health authorities, including meetings and consultations.
• Guide trial design input and labeling implications with clinical teams.
• Oversee preparation of IND/CTA submissions and major filings (BLA/NDA/MAA).
• Manage submission timelines, resources, and readiness frameworks.
• Ensure eCTD compliance and maintain submission infrastructure with Regulatory Operations.
• Build and mentor a high-performing regulatory affairs team.
• Monitor evolving regulatory guidances and communicate impact to leadership.

Skills

Regulatory strategy

Regulatory submissions

FDA/EMA knowledge

Leadership

Cross-functional collaboration

Global regulatory experience

Education

Bachelor's degree in life sciences/related field

Job description

Ardelyx is seeking a Senior Director of Regulatory Affairs to drive global regulatory strategy across the product portfolio. You will partner with Clinical Development, Medical Affairs, and Executive Leadership to accelerate development while ensuring full compliance with regulations.

You will lead interactions with FDA/EMA, oversee IND/CTA and BLA/NDA/MAA submissions, and mentor a high-performing regulatory team.