Ardelyx is a commercial-stage biopharmaceutical company focused on redefining treatment approaches for patients with significant unmet medical needs. By combining scientific innovation with a collaborative, purpose-driven culture, we strive to create meaningful impact for patients.
Team Ardelyx is united by a shared mission and guided by our core values: Passionate, Fearless, Dedicated, and Inclusive.
We foster an inclusive environment where employees are respected, supported, and empowered to make an impact — both within our company and in the lives of patients we serve.
Position Summary:
The Senior Director of Regulatory Affairs is a senior leader responsible for developing and executing global regulatory strategy across the product portfolio. This individual serves as a key strategic partner to Clinical Development, Medical Affairs, and Executive Leadership, driving regulatory decisions that accelerate product development while ensuring full compliance with applicable regulations and guidance.
Responsibilities:
- Develop and own global regulatory strategies for pipeline and marketed products, from early development through post-approval lifecycle management
- Serve as the primary regulatory strategist on cross-functional development teams (CDTs), 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 (CDER/CBER/CDRH as applicable), EMA, and other global health authorities, including Type A/B/C meetings, Scientific Advice, and Innovation Office engagements
- Partner with Clinical Development to provide input in designing early stage and registration-enabling trials, advising on endpoints, patient populations, statistical analysis plans, and labeling implications
- Review and provide regulatory input on protocols, IBs, CSRs, and other clinical documents to ensure alignment with regulatory strategy
- Lead preparation and execution of IND/CTA submissions and amendments; oversee clinical hold response strategy
- Drive BLA/NDA/MAA submission planning and execution, including authoring and reviewing Module 2 summaries and managing cross-functional submission teams
- Oversee preparation, review, and submission of major regulatory filings (IND, BLA/NDA, MAA) and post-approval submissions (CBEs, PASs, supplements, annual reports)
- Establish and maintain submission timelines, resource plans, and submission-readiness frameworks
- Ensure eCTD compliance and maintain submission infrastructure in partnership with Regulatory Operations
- Build, mentor, and retain a high-performing regulatory affairs team
- Monitor and interpret new and evolving FDA/EMA guidances, PDUFA commitments, and international regulatory developments; assess impact on programs and communicate to leadership
Qualifications:
- Bachelor's degree, advanced degree preferred, in life sciences, pharmacy, chemistry, or related field with 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 (21 CFR, ICH guidelines), with strong working knowledge of EMA and other major regulatory frameworks
- Proven track record of 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 (small molecule, biologics, gene therapy, combination products) desirable
- Global regulatory experience including ex-US submissions and agency interactions desirable
- Prior experience with Breakthrough Therapy, Fast Track, Accelerated Approval, or other expedited designation programs preferred
Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision), life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays.
Ardelyx is an equal opportunity employer.
We do not accept unsolicited resumes from search firms, or recruiters or similar vendors. Any such unsolicited resume submitted to any employee or through Company's career site without a valid, signed search agreement signed by Company's authorized representative will be deemed the property of the company, and no fees will be paid in the event of a hire. Company will have the right to hire any such candidate at its discretion without any financial obligation or fee owed to the vendor. Any verbal or written communication with a Company employee outside of this process will not be considered a binding agreement.
