Vice President, Regulatory Affairs

Aura Biosciences; Boston (MA); On-site; USD 295,000 - 375,000; Full time

Benefits offered by this job

Health insurance

401K with company match

Employee Stock Purchase Program (ESPP)

Unlimited PTO

Disability & life insurance

Job summary

Aura Biosciences, Inc. seeks a Vice President of Regulatory Affairs to lead global regulatory strategy for its oncology portfolio, with an emphasis on ocular oncology.

You will partner with senior leadership and cross-functional teams to shape development plans, risk assessments, and submission strategies across INDs, NDAs, BLAs, and MAAs. The role requires extensive interactions with FDA, EMA and other authorities and a track record of successful approvals in late-stage development.

Qualifications

• Advanced regulatory leadership experience in biotech/pharma, especially oncology.
• Proven ability to lead global NDA/BLA/MAA submissions and approvals.
• Strong track record of navigating US and international regulatory environments.

Responsibilities

• Develop and drive global regulatory strategies for Oncology portfolio including pivotal studies.
• Lead engagements with FDA, EMA, MHRA, PMDA, Health Canada and other agencies.
• Oversee submissions planning and alignment across Clinical, Nonclinical, CMC, Biostatistics, Quality and Medical Writing teams.
• Partner with Clinical Development, Medical Affairs and Commercial to inform development strategy and lifecycle management.

Skills

Regulatory strategy

Leadership

Executive communication

Cross-functional collaboration

Education

PhD/PharmD/MD or equivalent

Job description

About Aura Biosciences:

Aura Biosciences, Inc. is a clinical-stage biotechnology company focused on transforming ocular cancer care. Aura’s lead candidate, bel-sar (AU-011), is currently in late-stage development for early choroidal melanoma and in early-stage development in other ocular oncology indications and bladder cancer. Aura is headquartered in Boston, MA. Aura’s mission is to grow as an innovative global oncology company that positively transforms the lives of patients.

For more information, visit aurabiosciences.com. Follow us on X (formerly Twitter) @AuraBiosciences and visit us on LinkedIn.

Position Summary

The Vice President, Regulatory Affairs will provide strategic leadership for all global regulatory activities across the company's oncology portfolio, with primary focus on ocular oncology indications. This individual will be responsible for developing and executing innovative regulatory strategies that support late-stage development, registration, and commercialization initiatives.

The VP will serve as the regulatory leader for the organization, with accountability for holistic regulatory strategy and execution. This role will partner closely with Aura senior leadership, Clinical Development, Medical Affairs, Biometrics, CMC, Quality, and Commercial. The successful candidate will bring deep experience across all phases of oncology drug development and commercialization and a proven track record of leading interactions with global Health Authorities resulting in successful product approvals.

The VP will play a critical role in shaping development strategy, assessing regulatory risk, and ensuring that regulatory considerations are incorporated into key business decisions.

Key Responsibilities

Regulatory Strategy & Leadership

• Develop and execute global regulatory strategies for the company's oncology portfolio, including products advancing through pivotal and registration-enabling studies.
• Advise executive leadership and the Board of Directors on regulatory risks, opportunities, timelines, and competitive landscape considerations.
• Establish regulatory strategies that support global market expansion and lifecycle management.

Health Authority Engagement

• Accountable for all interactions with FDA, EMA, MHRA, PMDA, Health Canada, and other global regulatory agencies.
• Serve as the company's principal regulatory representative during key agency meetings, including End-of-Phase 2, Pre-NDA/BLA, Scientific Advice, and advisory committee interactions.
• Direct preparation of briefing documents, regulatory responses, and Health Authority communications.

Regulatory Submissions

• Lead regulatory strategy and execution for INDs, CTAs, NDA/BLA submissions, MAA filings, amendments, annual reports, and post-marketing commitments.
• Ensure alignment of Clinical, Nonclinical, CMC, Biostatistics, Quality, and Medical Writing teams in preparation for major submissions.
• Oversee development and review of regulatory documentation to ensure scientific excellence and compliance.
• Drive submission readiness activities for marketing applications and commercial launch.

Clinical Development Partnership

• Collaborate with Clinical Development leadership on study design, endpoint selection, statistical considerations, and global registration strategies.
• Provide regulatory guidance regarding oncology clinical development programs, including rare cancers and orphan indications.
• Partner on protocol development and major clinical program decisions.

Commercialization & Lifecycle Management

• Lead regulatory activities supporting product labeling, launch readiness, post-marketing commitments, and lifecycle management.
• Ensure ongoing compliance with regulatory requirements throughout the product lifecycle.

Corporate & Strategic Leadership

• Support business development, licensing evaluations, and due diligence activities.
• Contribute regulatory expertise to corporate strategy, investor communications, and strategic planning.

Qualifications

Required

• Advanced degree in a scientific discipline; 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, with 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.

Preferred

• Experience in ocular oncology, solid tumors, rare cancers, precision oncology, immuno-oncology, or targeted therapies.
• Prior experience supporting product approvals and commercial launches within an oncology-focused biotechnology company.
• Previous experience in a publicly traded biotechnology company.

Leadership Competencies

• Strategic thinker with the ability to translate regulatory requirements into actionable business strategies.
• Executive presence and aptitude 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.
• Demonstrate leadership by taking ownership of outcomes, holding yourself and others accountable.
• Communicate transparently and empower others to take responsibility for their own work.
• Create a culture where people feel trusted to act, accountable for results, and committed to our shared success.

Salary & Benefit Information

Salary Range: $295,000/yr - $375,000/yr

(Placement within the listed range depends on many factors including, but not limited to: geographic location, degree, years of experience, and internal company equity)

• 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