Senior Director, Regulatory Affairs

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Ardelyx, Inc.

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2007

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

Ardelyx is a biopharmaceutical company focused on creating first-in-class medicines to meet unmet medical needs. The company specializes in therapeutic areas such as chronic kidney disease with hyperphosphatemia and irritable bowel syndrome with constipation (IBS-C). Ardelyx is committed to patient care, innovation, and collaboration with the community, aiming to improve quality of life for patients through novel treatments. With core values of fearlessness, passion, dedication, and inclusivity, Ardelyx fosters a respectful and inclusive workplace. The company is engaged in clinical trials and partnerships to support its mission of patient-centered medical advancement.

📋 Description

• Develop and own global regulatory strategies for pipeline and marketed products from early development through post-approval lifecycle management • Serve as primary regulatory strategist on cross-functional development teams, aligning regulatory planning with clinical and commercial objectives • Provide regulatory intelligence and proactive risk assessment to senior leadership, including Board-level briefings when appropriate • Lead interactions with FDA, EMA, and other global health authorities, including Type A/B/C meetings, Scientific Advice, and Innovation Office engagements • Partner with Clinical Development on early-stage and registration-enabling trial design, endpoints, patient populations, statistical analysis plans, and labeling implications • Review and provide regulatory input on protocols, IBs, CSRs, and other clinical documents • Lead IND/CTA submissions and amendments and oversee clinical hold response strategy • Drive BLA/NDA/MAA submission planning and execution, including Module 2 summaries and cross-functional submission teams • Oversee major regulatory filings and post-approval submissions, including CBEs, PASs, supplements, and annual reports • Establish and maintain submission timelines, resource plans, and submission-readiness frameworks • Ensure eCTD compliance and maintain submission infrastructure with Regulatory Operations • Build, mentor, and retain a high-performing regulatory affairs team • Monitor and interpret FDA/EMA guidances, PDUFA commitments, and international regulatory developments; assess program impact and communicate to leadership

🎯 Requirements

• Bachelor's degree in life sciences, pharmacy, chemistry, or related field; advanced degree preferred • 12+ years of regulatory affairs experience in the pharmaceutical, biotechnology, or medical device industry, or equivalent experience • Demonstrated success leading BLA, NDA, or MAA submissions from initiation through approval • Deep expertise in FDA regulations and guidance, including 21 CFR and ICH guidelines • Strong working knowledge of EMA and other major regulatory frameworks • Proven track record leading Health Authority meetings and managing complex, high-stakes regulatory interactions • Experience in clinical regulatory strategy, including protocol design input, trial design, and endpoint negotiation with agencies • Strong leadership skills with experience managing and developing teams of regulatory professionals • RAC certification (RAPS) is a plus • Experience across multiple therapeutic areas or modalities is desirable • Global regulatory experience, including ex-US submissions and agency interactions, is desirable • Prior experience with Breakthrough Therapy, Fast Track, Accelerated Approval, or other expedited designation programs is preferred

🏖️ Benefits

• Annual bonus target, subject to eligibility and other requirements • Equity awards and equity incentive plans, subject to eligibility and other requirements • 401(k) plan with generous employer match • 12 weeks of paid parental leave • Up to 12 weeks of living organ and bone marrow leave • Health plans: medical, prescription drug, dental, and vision • Life insurance and disability • Flexible time off • Annual Winter Holiday shut down • At least 11 paid holidays