Executive Director, Global Regulatory Strategy

Ardelyx, Inc.; San Diego (CA); Sur place; USD 282 000 - 344 000; Plein temps

Avantages offerts par ce poste

401(k) match

Parental leave (12 weeks)

Organ/bone marrow leave (12 weeks)

Equity incentive plans

Health plans (medical, dental, vision)

Life insurance

Disability coverage

Flexible time off

Holiday shutdown

Paid holidays

Résumé du poste

Ardelyx, Inc. is seeking an Executive Director of Regulatory Affairs to lead global regulatory strategy for the portfolio. You will partner with Clinical Development, Medical Affairs, and Executive Leadership to accelerate development while ensuring compliance.

Responsibilities include cross-functional strategy, regulatory intelligence, and managing submissions with FDA/EMA and other authorities. A senior leader with experience in BLA/NDA/MAA submissions is required.

Qualifications

• Bachelor's degree required; advanced degree preferred.
• 12–15 years regulatory affairs experience.
• Proven success leading BLA, NDA, or MAA submissions.
• Deep knowledge of FDA regulations and guidance (21 CFR, ICH).
• Global regulatory experience including ex-US submissions and agency interactions.

Responsabilités

• Develop and own global regulatory strategies for pipeline and marketed products.
• Serve as primary regulatory strategist on cross-functional development teams.
• Lead interactions with FDA, EMA, and other global health authorities.
• Provide regulatory input on protocols, IBs, CSRs, and other documents to align with strategy.
• Lead preparation and execution of IND/CTA submissions and amendments; manage response strategies.
• Drive BLA/NDA/MAA submission planning and execution and manage cross-functional teams.
• Oversee major regulatory filings and post-approval submissions.

Formation

Bachelor's degree, advanced degree preferred

12–15 years regulatory affairs experience

Description du poste

Ardelyx, Inc. is seeking an Executive Director of Regulatory Affairs to lead global regulatory strategy for the portfolio. You will partner with Clinical Development, Medical Affairs, and Executive Leadership to accelerate development while ensuring compliance.

Responsibilities include cross-functional strategy, regulatory intelligence, and managing submissions with FDA/EMA and other authorities. A senior leader with experience in BLA/NDA/MAA submissions is required.