For companies:
For professionals:
For everyone:
For developers:
Responsibilities
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 managementServe as the primary regulatory strategist on cross-functional development teams (CDTs), aligning regulatory planning with clinical and commercial objectivesProvide regulatory intelligence and proactive risk assessment to senior leadership, including Board-level briefings when appropriateLead 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 engagementsPartner with Clinical Development to provide input ising on endpoints, patient populations, statistical analysis plans, and labeling implicationsReview and provide regulatory input on protocols, IBs, CSRs, and other clinical documents to ensure alignment with regulatory strategyLead preparation and execution of IND/CTA submissions and amendments; oversee clinical hold response strategyDrive BLA/NDA/MAA submission planning and execution, including authoring and reviewing Module 2 summaries and managing cross-functional submission teamsOversee preparation, review, and submission of major regulatory filings (IND, BLA/NDA, MAA) and post-approval submissions (CBEs, PASs, supplements, annual reports)Establish and maintaource plans, and submission-readiness frameworksEnsure eCTD compliance and maintain submission infrastructure in partnership with Regulatory OperationsBuild, mentor, and retain a high-performing regulatory affairs teamMonitor and interpret new and evolving FDA/EMA guidances, PDUFA commitments, and international regulatory developments; assess impact on programs and communicate to leadershipQualifications:Bachelor's degree, advanced degree preferred, rmacy, chemistry, or related field with 12+ years of regulatory affairs experience technology or medical device industry, or equivalent experienceDemonstrated success leading BLA, NDA, or MAA submissions from initiation through approvalDeep expertise in FDA regulations and guidance (21 CFR, ICH guidelines), with strong working knowledge of EMA and other major regulatory frameworksProven track record of leading Health Authority meetings and managing complex, high-stakes regulatory interactionsExperience luding protocol design input, trial design, and endpoint negotiation with agenciesStrong leadership skills with experience managing and developing teams of regulatory professionalsRAC certification (RAPS) is a plusExperience across multiple therapeutic areas or modalities (small molecule, biologics, gene therapy, combination products) desirableGlobal regulatory experience including ex-US submissions and agency interactions desirablePrior experience with Breakthrough Therapy, Fast Track, Accelerated Approval, or other expedited designation programs preferredThe anticipated annualized base pay range for this full-time position is $259,000 - $317,000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements.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.
This job post is closed.