Senior Director, Regulatory Affairs Strategy

The Role:

The Senior Director, Regulatory Affairs Strategy is a senior individual contributor and people leader responsible for shaping, influencing, and executing global regulatory strategies across one or more complex development programs. This role serves as a critical bridge between program-level execution and portfolio-level strategic alignment.

The Senior Director will provide deep regulatory expertise, lead health authority interactions, mentor regulatory leaders, and partner closely with cross-functional and Regulatory leadership to ensure consistent, high-quality regulatory strategies that support corporate objectives. The role requires strong strategic judgment, the ability to navigate ambiguity, and comfort operating in a fast-paced, evolving biotech environment.

Key Responsibilities:

Regulatory Strategy & Leadership

• Lead the development and execution of innovative global regulatory strategies to expedite development, maximize probability of success, and mitigate regulatory risk across assigned programs.
• Serve as a core regulatory strategist for complex and/or high-priority programs, with accountability for overall regulatory direction and outcomes.
• Anticipate and proactively address regulatory challenges, translating external regulatory trends and guidance into actionable strategies.
• Ensure alignment between program-level strategies and broader portfolio and corporate regulatory objectives.

Health Authority Engagement

• Lead and/or play a prominent role in interactions with FDA and other global Health Authorities, including briefing document development, meeting preparation, negotiation strategy, and follow-up.
• Provide strategic oversight and guidance on responses to regulatory questions, information requests, and post-meeting commitments.

Cross‑Functional Partnership

• Act as the primary regulatory partner on cross-functional development teams, influencing decision-making across R&D, Clinical, CMC, Quality, Pharmacovigilance, and Commercial functions as appropriate.
• Clearly communicate regulatory risks, opportunities, and recommendations to senior management and key stakeholders.
• Represent Regulatory Affairs Strategy on cross-functional governance forums and committees as needed.

People Leadership & Mentorship

• Provide direct or matrix leadership to Regulatory Strategy personnel (e.g., Managers, Associate Directors, Directors), including coaching, mentoring, and development of future regulatory leaders.
• Support performance management, talent assessment, and succession planning in partnership with Regulatory leadership.
• Foster a culture of accountability, collaboration, and continuous learning within the Regulatory Affairs organization.

Operational Excellence & Oversight

• Oversee and contribute to the planning, preparation, and review of high-quality global regulatory submissions, including INDs, BLAs, MAAs, CTAs/IMPDs, amendments, annual reports, and briefing packages.
• Ensure regulatory deliverables are strategically sound, internally aligned, and completed within established timelines.
• Manage or oversee external consultants and vendors to ensure efficient execution and high-quality outcomes.

Requirements:

• Bachelor’s degree in a scientific discipline required; advanced degree (Master’s or PhD) strongly preferred.
• Minimum of 12–15+ years of regulatory experience in the biopharmaceutical industry, with demonstrated progression in scope and complexity.
• Significant experience developing and executing global regulatory strategies for biologics across clinical development and, preferably, marketing applications.
• Demonstrated leadership in Health Authority interactions, including FDA and major ex‑US agencies.
• Strong understanding of global regulatory requirements, guidance, and processes (FDA, EMA, ICH, and other key regions).
• Experience leading or contributing to INDs and BLAs; MAA experience preferred.
• Proven ability to think strategically while remaining hands-on as needed.
• Excellent written and verbal communication skills, with the ability to influence senior leaders and cross-functional partners.
• Experience mentoring and developing regulatory talent in a matrixed, fast-paced environment.
• Comfort operating with ambiguity and shifting priorities in a high-growth biotech setting.

Work Environment:

• Remote-based
• Dynamic, interactive, fast-paced, and entrepreneurial environment
• Domestic or international travel are required (10-20%)