Senior Director, Regulatory Affairs
Ardelyx, Inc.
August 10, 2026
Remote friendly (Newark, CA)
United States
Corporate Functions
Responsibilities:
- Develop and own global regulatory strategies for pipeline and marketed products (early development through post-approval).
- Serve as primary regulatory strategist on cross-functional development teams (CDTs), aligning regulatory planning with clinical and commercial goals.
- Provide regulatory intelligence and proactive risk assessment to senior leadership.
- Lead health authority interactions with FDA and EMA (Type A/B/C meetings, Scientific Advice, Innovation Office).
- Partner with Clinical Development on early-stage and registration-enabling trial design (endpoints, patient populations, SAPs, labeling implications).
- Review regulatory input on protocols, investigator brochures (IBs), clinical study reports (CSRs), and other clinical documents.
- Lead IND/CTA submissions and amendments; oversee clinical hold response strategy.
- Plan and execute BLA/NDA/MAA submissions; author/review Module 2 summaries and manage cross-functional submission teams.
- Oversee major filings and post-approval submissions (CBEs, PASs, supplements, annual reports).
- Maintain submission timelines, resources, readiness frameworks, and eCTD compliance.
- Build, mentor, and retain a high-performing regulatory affairs team.
- Monitor and interpret evolving FDA/EMA guidance and international developments.
Qualifications:
- Bachelor’s degree (advanced degree preferred) in life sciences/pharmacy/chemistry or related field; 12+ years regulatory affairs experience in pharma/biotech/medical devices (or equivalent).
- Demonstrated success leading BLA/NDA/MAA from initiation through approval.
- Deep FDA (21 CFR, ICH) expertise; strong knowledge of EMA/global regulatory frameworks.
- Experience leading health authority meetings and complex regulatory interactions.
- Clinical regulatory strategy experience (protocol/trial design and endpoint negotiation).
- Strong leadership experience managing regulatory teams.
- RAC (RAPS) preferred; multi-modality/global experience desired; expedited programs preferred.
Benefits:
- 401(k) with employer match; 12 weeks paid parental leave; up to 12 weeks living organ/bone marrow leave; health plans (medical, prescription drug, dental, vision); life insurance & disability; flexible time off; Winter Holiday shut down; 11+ paid holidays; equity incentive plans.
- Develop and own global regulatory strategies for pipeline and marketed products (early development through post-approval).
- Serve as primary regulatory strategist on cross-functional development teams (CDTs), aligning regulatory planning with clinical and commercial goals.
- Provide regulatory intelligence and proactive risk assessment to senior leadership.
- Lead health authority interactions with FDA and EMA (Type A/B/C meetings, Scientific Advice, Innovation Office).
- Partner with Clinical Development on early-stage and registration-enabling trial design (endpoints, patient populations, SAPs, labeling implications).
- Review regulatory input on protocols, investigator brochures (IBs), clinical study reports (CSRs), and other clinical documents.
- Lead IND/CTA submissions and amendments; oversee clinical hold response strategy.
- Plan and execute BLA/NDA/MAA submissions; author/review Module 2 summaries and manage cross-functional submission teams.
- Oversee major filings and post-approval submissions (CBEs, PASs, supplements, annual reports).
- Maintain submission timelines, resources, readiness frameworks, and eCTD compliance.
- Build, mentor, and retain a high-performing regulatory affairs team.
- Monitor and interpret evolving FDA/EMA guidance and international developments.
Qualifications:
- Bachelor’s degree (advanced degree preferred) in life sciences/pharmacy/chemistry or related field; 12+ years regulatory affairs experience in pharma/biotech/medical devices (or equivalent).
- Demonstrated success leading BLA/NDA/MAA from initiation through approval.
- Deep FDA (21 CFR, ICH) expertise; strong knowledge of EMA/global regulatory frameworks.
- Experience leading health authority meetings and complex regulatory interactions.
- Clinical regulatory strategy experience (protocol/trial design and endpoint negotiation).
- Strong leadership experience managing regulatory teams.
- RAC (RAPS) preferred; multi-modality/global experience desired; expedited programs preferred.
Benefits:
- 401(k) with employer match; 12 weeks paid parental leave; up to 12 weeks living organ/bone marrow leave; health plans (medical, prescription drug, dental, vision); life insurance & disability; flexible time off; Winter Holiday shut down; 11+ paid holidays; equity incentive plans.