Executive Director, Regulatory Affairs

Ardelyx, Inc.; Newark (CA); On-site; USD 282,000 - 344,000; Full time

Benefits offered by this job

401(k) match

Parental leave 12 weeks

Organ and bone marrow leave up to 12 w

Equity incentives

Health plans (medical, prescription,/d

Life insurance

Disability

Flexible time off

Winter holiday shutdown

11 paid holidays

Job summary

Ardelyx, Inc. in Newark, CA seeks an Executive Director of Regulatory Affairs to design and execute global regulatory strategies across the portfolio.

You will partner with Clinical Development, Medical Affairs, and Executive Leadership to accelerate development while ensuring compliance. You will lead interactions with FDA and EMA, oversee IND/CTA submissions and major filings, and mentor a high-performing regulatory team.

Qualifications

• Bachelor's degree or higher with 12–15 years of regulatory affairs experience in pharma/biotech/medical device
• Proven success leading BLA/NDA/MAA submissions from start to finish
• Strong knowledge of FDA regulations (21 CFR) and ICH guidelines, with EMA familiarity

Responsibilities

• Develop and own global regulatory strategies for pipeline and marketed products, from development through post-approval
• Lead cross-functional development teams and align regulatory planning with clinical and commercial goals
• Provide regulatory intelligence and risk assessments to senior leadership, including Board briefings
• Oversee FDA/EMA interactions, including meetings, scientific advice, and innovative programs
• Guide trial design input, endpoints, and labeling implications in collaboration with Clinical Development
• Review regulatory documents (IBs, CSRs, protocols) to ensure alignment with strategy
• Lead IND/CTA submissions and post-approval filings (BLA/NDA/MAA; CBEs, PASs, supplements)
• Establish timelines, resources, and submission readiness with Regulatory Operations
• Mentor and grow a high-performing regulatory affairs team
• Monitor evolving FDA/EMA guidances and PDUFA commitments, communicating impact to leadership

Skills

Regulatory strategy leadership

FDA regulatory expertise

BLA/NDA/MAA submissions

Cross-functional leadership

Global regulatory affairs

Regulatory risk assessment

Education

Bachelor's degree in life sciences or related field

Job description

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 Executive 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 12-15 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

The anticipated annualized base pay range for this full-time position is $282,000 - $344,000. 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

• 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
• 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.