Senior Director, Regulatory Affairs Strategy

📋 Description

• Lead the formulation and implementation of innovative global regulatory strategies to accelerate development, enhance the likelihood of success, and minimize regulatory risks across designated programs.

• Act as a key regulatory strategist for complex and/or high-priority initiatives, being accountable for overall regulatory direction and outcomes.

• Anticipate and proactively tackle regulatory challenges, converting external regulatory trends and guidelines into actionable strategies.

• Ensure consistency between program-level strategies and the broader objectives of the portfolio and corporate regulatory framework.

• Spearhead and/or take a significant role in engagements with the FDA and other global health authorities, including the development of briefing documents, meeting preparations, negotiation strategies, and follow-ups.

• Provide strategic oversight and guidance on responses to regulatory inquiries, information requests, and commitments following meetings.

• Serve 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.

• Communicate regulatory risks, opportunities, and recommendations clearly to senior management and key stakeholders.

• Represent Regulatory Affairs Strategy in cross-functional governance forums and committees as necessary.

• Offer direct or matrix leadership to Regulatory Strategy personnel (e.g., Managers, Associate Directors, Directors), which includes coaching, mentoring, and developing the next generation of regulatory leaders.

• Support performance management, talent assessment, and succession planning in collaboration with Regulatory leadership.

• Cultivate a culture of accountability, collaboration, and continuous learning within the Regulatory Affairs organization.

• Oversee and contribute to the planning, preparation, and review of high-quality global regulatory submissions, such as INDs, BLAs, MAAs, CTAs/IMPDs, amendments, annual reports, and briefing packages.

• Ensure that regulatory deliverables are strategically sound, internally aligned, and completed within established deadlines.

• Manage or supervise external consultants and vendors to guarantee efficient execution and high-quality outcomes.

⛳️ Requirements

• A Bachelor’s degree in a scientific field is required; an advanced degree (Master’s or PhD) is highly preferred.

• A minimum of 12–15+ years of regulatory experience in the biopharmaceutical industry, demonstrating growth in scope and complexity.

• Extensive experience in developing and implementing global regulatory strategies for biologics throughout clinical development and, ideally, marketing applications.

• Proven leadership in interactions with health authorities, including the FDA and major non-U.S. agencies.

• Strong grasp of global regulatory requirements, guidelines, and processes (FDA, EMA, ICH, and other key regions).

• Experience leading or contributing to INDs and BLAs; MAA experience is preferred.

• Demonstrated ability to think strategically while remaining hands-on when necessary.

• Exceptional written and verbal communication skills, with the capacity to influence senior leaders and cross-functional partners.

• Experience in mentoring and developing regulatory talent in a matrixed, fast-paced environment.

• Comfort in navigating ambiguity and shifting priorities in a high-growth biotech setting.

🏝️ Benefits

• A comprehensive range of medical, dental, vision, 401k, and additional benefits.

• Unlimited paid time off.

• Parental leave.