Senior Director, Regulatory Affairs Strategy

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

📋 Description

• Lead the formulation and implementation of innovative global regulatory strategies aimed at accelerating development, enhancing the likelihood of success, and minimizing regulatory risks for assigned programs.

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

• Proactively foresee and tackle regulatory challenges, converting external regulatory trends and guidelines into actionable strategies.

• Ensure coherence between program-level strategies and the wider portfolio and corporate regulatory objectives.

• Take the lead or play 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-up actions.

• Offer strategic oversight and guidance on regulatory inquiries, information requests, and commitments made post-meeting.

• 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 necessary.

• Clearly articulate regulatory risks, opportunities, and recommendations to senior management and key stakeholders.

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

• Provide direct or matrix leadership to Regulatory Strategy personnel (e.g., Managers, Associate Directors, Directors), which includes coaching, mentoring, and the development of future regulatory leaders.

• Assist in performance management, talent evaluation, 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, including INDs, BLAs, MAAs, CTAs/IMPDs, amendments, annual reports, and briefing packages.

• Ensure that regulatory deliverables are strategically sound, aligned internally, and completed within set timelines.

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

⛳️ Requirements

• Bachelor's degree in a scientific discipline is required; an advanced degree (Master’s or PhD) is strongly preferred.

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

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

• Proven leadership in interactions with health authorities, including the FDA and major ex-US agencies.

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

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

• Established capacity to think strategically while remaining hands-on when necessary.

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

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

• Comfortable operating amidst ambiguity and shifting priorities in a high-growth biotech environment.

🏝️ Benefits

• Full range of medical, dental, vision, 401k, and other benefits.

• Unlimited paid time off.

• Parental leave.