Senior Director, Regulatory Affairs
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Job Description
Senior regulatory leader guiding global drug approvals for Ardelyx, a commercial-stage biopharmaceutical company. Driving FDA, EMA, and worldwide submissions from development through post-approval lifecycle management.
Responsibilities:
- Develop and own global regulatory strategies for pipeline and marketed products from early development through post-approval lifecycle management
- Serve as primary regulatory strategist on cross-functional development teams, 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, EMA, and other global health authorities, including Type A/B/C meetings, Scientific Advice, and Innovation Office engagements
- Partner with Clinical Development on early-stage and registration-enabling trial design, endpoints, patient populations, statistical analysis plans, and labeling implications
- Review and provide regulatory input on protocols, IBs, CSRs, and other clinical documents
- Lead IND/CTA submissions and amendments and oversee clinical hold response strategy
- Drive BLA/NDA/MAA submission planning and execution, including Module 2 summaries and cross-functional submission teams
- Oversee major regulatory filings and post-approval submissions, including CBEs, PASs, supplements, and annual reports
- Establish and maintain submission timelines, resource plans, and submission-readiness frameworks
- Ensure eCTD compliance and maintain submission infrastructure with Regulatory Operations
- Build, mentor, and retain a high-performing regulatory affairs team
- Monitor and interpret FDA/EMA guidances, PDUFA commitments, and international regulatory developments; assess program impact and communicate to leadership
Requirements:
- Bachelor's degree in life sciences, pharmacy, chemistry, or related field; advanced degree preferred
- 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, including 21 CFR and ICH guidelines
- Strong working knowledge of EMA and other major regulatory frameworks
- Proven track record 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 is desirable
- Global regulatory experience, including ex-US submissions and agency interactions, is desirable
- Prior experience with Breakthrough Therapy, Fast Track, Accelerated Approval, or other expedited designation programs is preferred
Benefits:
- Annual bonus target, subject to eligibility and other requirements
- Equity awards and equity incentive plans, subject to eligibility and other requirements
- 401(k) plan with generous employer match
- 12 weeks of paid parental leave
- Up to 12 weeks of living organ and bone marrow leave
- 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
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