Vice President, Regulatory Affairs

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Formulate and implement comprehensive global regulatory strategies for the company's oncology portfolio.

• Provide counsel to executive leadership and the Board of Directors regarding regulatory risks, opportunities, timelines, and considerations related to the competitive landscape.

• Develop regulatory strategies that promote global market expansion and effective lifecycle management.

• Lead engagement with FDA, EMA, MHRA, PMDA, Health Canada, and other international regulatory bodies.

• Act as the primary regulatory representative during essential agency meetings.

• Manage the preparation of briefing documents, regulatory responses, and communications with Health Authorities.

• Oversee strategy and execution for INDs, CTAs, NDA/BLA submissions, MAA filings, amendments, annual reports, and post-marketing commitments.

• Coordinate efforts across Clinical, Nonclinical, CMC, Biostatistics, Quality, and Medical Writing teams for significant submissions.

• Ensure the regulatory documentation reflects scientific excellence and compliance standards.

• Propel submission readiness for marketing applications and commercial launches.

• Collaborate on study design, endpoint selection, statistical considerations, global registration strategies, protocols, and key decisions regarding major clinical programs.

• Offer regulatory insight for oncology development initiatives, including rare cancers and orphan indications.

• Direct activities that support product labeling, launch preparedness, post-marketing commitments, and lifecycle management.

• Maintain ongoing compliance throughout the product's lifecycle.

• Assist in business development, licensing evaluations, and due diligence processes.

• Provide regulatory expertise to inform corporate strategy, investor communications, and strategic planning initiatives.

⛳️ Requirements

• An advanced degree in a scientific discipline is required.

• A PhD, PharmD, MD, or equivalent is strongly preferred.

• Over 15 years of progressive experience in Regulatory Affairs or related fields within biotechnology and/or pharmaceutical organizations.

• Considerable experience in leading regulatory strategy for late-stage clinical development.

• Experience in oncology and combination product development is preferred.

• Proven success in leading NDA, BLA, MAA, or equivalent global registration submissions and securing approvals.

• Comprehensive understanding of U.S. and international regulatory frameworks governing drug and device development.

• Extensive experience in direct interactions with FDA and other major global Health Authorities.

• Preference for experience in ocular oncology, solid tumors, rare cancers, precision oncology, immuno-oncology, or targeted therapies.

• Previous support for product approvals and commercial launches within an oncology-focused biotechnology company is preferred.

• Experience in a publicly traded biotechnology company is also preferred.

• Ability to translate regulatory requirements into actionable business strategies.

• Possess executive presence and the capability to influence stakeholders at all organizational levels.

• Strong judgment with the ability to balance regulatory risk alongside development objectives.

• Outstanding communication, negotiation, and relationship-building skills.

• Capable of navigating complex and rapidly changing regulatory environments.

• Demonstrate leadership, ownership of outcomes, accountability, transparent communication, and the empowerment of others.

🏝️ Benefits

• Comprehensive health insurance with FULL premium coverage.

• 401K plan with company matching contributions.

• Employee Stock Purchase Program (ESPP).

• Unlimited paid time off (PTO).

• Company-paid short & long-term disability insurance and life insurance.