Senior Director, Regulatory Affairs
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 submi