Executive Director,Regulatory Affairs Strategy – Cell and Gene Therapy Job Baltimore area,Maryland USA,Business

Own the end‑to‑end global regulatory strategy for a cell and gene therapy product or franchise of exceptional complexity and strategic importance, from current stage through BLA submission, approval, and lifecycle management.
Represent Regulatory Affairs on Global Product Teams, provide strategic regulatory advice, and be accountable for all regulatory activities that shape development plans, risk management, and commercialization outcomes.
Lead strategy for major health authority interactions, responses to critical information requests, expedited pathway designations, BLA development and submission, major post‑submission interactions, and complex labeling negotiations to secure competitive labels and timely approvals.
Maintain a deep and current working knowledge of relevant disease areas, evolving scientific evidence, regulatory policy, and the external environment; establish senior external relationships to influence perspectives and maintain competitive advantage.
Lead one or more Global Regulatory Strategy Teams focused on indications, programs, or franchise priorities; provide leadership, coaching, and performance feedback; line‑manage 3–7 regulatory team members; contribute to succession planning, capability building, and development of senior regulatory talent.
Deliver objective executive‑level assessments of emerging data against program and portfolio aspirations; update senior management on risks, mitigation activities, probability of success, and strategic options.
Be accountable for delivery of all project‑related regulatory milestones, including probability of regulatory success assessments, mitigation planning, approval strategy, lifecycle planning; lead preparation of regulatory strategy documents and target product labeling; ensure strong strategic planning and construction of the global dossier and core prescribing information; oversee maintenance and compliance for marketed brands where applicable.
Lead, participate in, and promote major non‑project functional or cross‑functional initiatives; drive the development and implementation of novel regulatory tools, technologies, and modern ways of working that improve quality and speed.
Partner with marketing companies, regional regulatory affairs teams, and senior cross‑functional stakeholders to influence developing views, guidance, and regulatory policy interpretation; coordinate across therapeutic areas and regulatory teams to deliver our cell therapies to patients.

Requirements

An advanced degree in a science‑related field and at least ten or more years of experience and/or appropriate knowledge/experience.
Demonstrated extensive success in cell and/or gene therapy regulatory strategy.
Deep understanding of global regulatory science and integration with program, franchise, and portfolio strategy.
Long‑standing experience of overall drug/biologic development processes and strategies for high profile, highly complex, novel, or first‑in‑class development programs.
Experience with product development in the following therapeutic areas: oncology, autoimmune, rare diseases, neurology.
Broad background of experience working in the pharmaceutical business and prior experience in several areas within regulatory affairs.
Proven experience leading regulatory and cross‑functional teams, influencing senior stakeholders, and operating effectively in complex matrix environments.
Ability to think strategically and critically at enterprise level and evaluate risks to regulatory and business activities.
Previous significant experience in leading Health Authority interaction in major markets.
Excellent oral, written, and presentation skills.
Strong organizational skills.
Ability to work in a fast‑paced environment in a hands‑on fashion.
Flexible and proactive, with the ability to manage multiple projects and successfully adapt to changing business needs and priorities.
Experience working on due diligence activities and in a business alliance environment.
Experience in leading and growing people through line management, coaching, or mentorship.
Contribution to non‑project business initiatives at a portfolio, franchise, or enterprise level.
Experience contributing to external policy, regulatory science, or industry advocacy initiatives.

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Executive Director, Regulatory Affairs Strategy – Cell and Gene Therapy