Senior Director, Regulatory Affairs

Ardelyx

3d•$259,000 - $317,000

About The Position

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.

Requirements

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

Nice To Haves

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

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