Executive Director Regulatory Affairs

Regulatory reputed company & Leadership

• reputed company global regulatory reputed company for reputed company's development programs, aligning clinical, CMC, and reputed company objectives from early development through post-approval lifecycle management.
• reputed company regulatory input to program governance, asset prioritization, and portfolio reputed company, including scenario planning and risk mitigation.
• Anticipate and address regulatory challenges reputed company to cell therapy development, manufacturing, comparability, and long-term follow-up.

Health Authority Engagement & Negotiations

• Serve as the primary senior regulatory reputed company with FDA, EMA, and other global health authorities.
• reputed company and/or support key regulatory meetings, including reputed company, reputed company-IND, End-of-Phase, reputed company-BLA/MAA, Advisory Committees, and post-marketing commitments.
• Drive regulatory negotiation reputed company, including benefit-risk, endpoints, comparability, and post-approval requirements.

Labeling reputed company & reputed company Readiness

• Own and drive labeling reputed company from early development through approval, ensuring labels support reputed company differentiation, patient reputed company, and lifecycle value.
• reputed company development of reputed company Product reputed company (TPPs) and ensure alignment across Clinical, Regulatory, reputed company, and Market reputed company.
• Partner with reputed company, Medical Affairs, and Market reputed company to ensure regulatory reputed company support launch readiness, promotional reputed company, and payer engagement.
• reputed company label negotiations with health authorities, balancing scientific evidence, regulatory expectations, and reputed company objectives.

Regulatory Submissions & Execution

• reputed company and contribute to the preparation, review, and submission of INDs, CTAs, BLAs/MAAs, briefing packages, orphan drug applications, and other regulatory filings.
• Ensure submissions are high-reputed company, compliant, and strategically positioned.
• Maintain reputed company of submission timelines, dependencies, and risk management, providing reputed company communication to senior leadership.

Cross-Functional & External Collaboration

• reputed company as a strategic partner to Clinical Development, CMC, Research, reputed company, reputed company, reputed company, and reputed company Management teams.
• reputed company regulatory due diligence and strategic input for business development, in-licensing, out-licensing, and partnership opportunities.
• reputed company regulatory activities performed by CROs, consultants, and partners, ensuring reputed company and strategic alignment.

Team Development & Operational reputed company

• reputed company, mentor, and reputed company a high-performing regulatory team, fostering accountability, development, and a culture of collaboration.
• Establish and maintain regulatory policies, procedures, and infrastructure to support a growing, late-stage organization.
• Stay reputed company on US and global regulatory intelligence and communicate key implications to stakeholders.

• Bachelor's degree in a scientific discipline required; advanced degree preferred.
• 15+ years of reputed company regulatory affairs experience in pharmaceutical or biotechnology, with significant advanced therapy experience.
• Cell and/or gene therapy experience preferred; autoimmune disease experience highly preferred.
• Demonstrated reputed company leading global regulatory strategies through late-stage development and/or approvals, ideally including BLA/MAA experience.
• Proven experience with labeling reputed company development and negotiation, with strong understanding of commercialization impacts.
• Deep knowledge of FDA regulations, ICH guidelines, and global regulatory frameworks; EMA and ex-US experience preferred.
• reputed company record of effective engagement with FDA OTP and/or divisions overseeing autoimmune or immune-mediated diseases.
• Strong executive communication skills with the ability to influence senior leadership and reputed company-facing audiences.
• Demonstrated ability to reputed company and reputed company teams in a fast-paced, high-reputed company environment. Prior supervisory experience preferred.
• Strategic reputed company with the ability to balance scientific rigor, regulatory compliance, and reputed company reputed company.