Vice President, Regulatory Affairs
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Job Description
Regulatory executive guiding global oncology drug strategies at Aura Biosciences, an ocular cancer biotechnology company. Leading health-authority engagement, submissions, approvals, and commercialization readiness.
Responsibilities:
- Develop and execute global regulatory strategies for the company's oncology portfolio
- Advise executive leadership and the Board of Directors on regulatory risks, opportunities, timelines, and competitive landscape considerations
- Establish regulatory strategies supporting global market expansion and lifecycle management
- Lead interactions with FDA, EMA, MHRA, PMDA, Health Canada, and other global regulatory agencies
- Serve as the principal regulatory representative in key agency meetings
- Direct preparation of briefing documents, regulatory responses, and Health Authority communications
- Lead strategy and execution for INDs, CTAs, NDA/BLA submissions, MAA filings, amendments, annual reports, and post-marketing commitments
- Align Clinical, Nonclinical, CMC, Biostatistics, Quality, and Medical Writing teams for major submissions
- Oversee regulatory documentation for scientific excellence and compliance
- Drive submission readiness for marketing applications and commercial launch
- Collaborate on study design, endpoint selection, statistical considerations, global registration strategies, protocols, and major clinical program decisions
- Provide regulatory guidance for oncology development programs, including rare cancers and orphan indications
- Lead activities supporting product labeling, launch readiness, post-marketing commitments, and lifecycle management
- Ensure ongoing compliance throughout the product lifecycle
- Support business development, licensing evaluations, and due diligence
- Contribute regulatory expertise to corporate strategy, investor communications, and strategic planning
Requirements:
- Advanced degree in a scientific discipline required
- PhD, PharmD, MD, or equivalent strongly preferred
- 15+ years of progressive Regulatory Affairs experience or related experience within biotechnology and/or pharmaceutical organizations
- Significant experience leading regulatory strategy for late-stage clinical development
- Oncology and combination product development preferred
- Demonstrated success leading NDA, BLA, MAA, or equivalent global registration submissions and approvals
- Deep knowledge of U.S. and international regulatory frameworks governing drug and device development
- Extensive experience interacting directly with FDA and other major global Health Authorities
- Experience in ocular oncology, solid tumors, rare cancers, precision oncology, immuno-oncology, or targeted therapies preferred
- Prior experience supporting product approvals and commercial launches within an oncology-focused biotechnology company preferred
- Previous experience in a publicly traded biotechnology company preferred
- Ability to translate regulatory requirements into actionable business strategies
- Executive presence and ability to influence stakeholders across all levels of the organization
- Strong judgment and ability to balance regulatory risk with development objectives
- Exceptional communication, negotiation, and relationship-building skills
- Ability to navigate complex and rapidly evolving regulatory landscapes
- Leadership, ownership of outcomes, accountability, transparent communication, and empowerment of others
Benefits:
- Health insurance with FULL premium coverage
- 401K with company match
- Employee Stock Purchase Program (ESPP)
- Unlimited paid time off (PTO)
- Company-paid short & long-term disability insurance and life insurance
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