Executive Director, Regulatory Affairs Strategy - Cell Therapy

We need to output HTML fragment with sections: headings

for sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. We need to parse the job posting. Job Title: Executive Director, Regulatory Affairs Strategy - Cell Therapy Available locations: NYC, NYGaithersburg, MDBoston, MASouth San Francisco, CASanta Monica, CA Introduction To Role: paragraph. Accountabilities: list of responsibilities. Essential Skills/Experience: list. Desirable Skills/Experience: list. Then there is a paragraph about in-person working: "When we put unexpected teams...". That's about work schedule: "we work, on average, a minimum of three days per week from the office." So schedule info. Competitive Salary And Benefits Package On Offer: includes salary range, bonus, equity, retirement, benefits. Then more about benefits. Then "Join us..." etc. We need to remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, application instructions. At end there is EEO statement, date posted, closing date, mission statement, etc. Those should be removed. We need to preserve all substantive information. We need to decide sections: - About the role: could be the Introduction To Role paragraph. - Responsibilities: the Accountabilities bullet points. - Requirements / Qualifications: Essential Skills/Experience (maybe as Requirements). Could also separate Qualifications (education) and Skills. But we can combine. - Desirable Skills/Experience could be under Qualifications or Skills as additional. - Benefits: the benefits paragraph. - Pay: salary range and bonus info. - Schedule: the in-person working paragraph. We must not repeat job title as heading. We must not put Job ID/requisition numbers as headings. We must not create sections with filler like "commensurate with experience". Not present. We need to output only HTML fragment. Let's extract content. Introduction To Role: "Are you ready to set the global regulatory direction for first-in-class cell therapies and turn science into approved medicines? Do you see yourself steering complex programs to competitive labels and rapid, global patient access? This role leads the strategy for our most visible and complex cell therapy programs, translating breakthrough science into timely approvals and meaningful labels that unlock lifecycle value. You will work across discovery through commercialization, bringing clarity and pace to decision-making and ensuring our therapies reach patients with unmet needs. You will directly shape how we engage with health authorities, define target product labeling, and accelerate submissions across multiple indications and modalities. As a senior leader, you will build capability, coach regulatory talent, and influence policy and guidance to sustain a competitive edge for our pipeline and portfolio." That's a paragraph. Accountabilities: list of bullet points (each starting with a bold heading?). Let's extract each bullet: - Global Regulatory Strategy Leadership: Own the end-to-end global regulatory strategy for a cell therapy product or franchise of exceptional complexity and strategic importance, from current stage through BLA submission, approval, and lifecycle management; may serve in a dual role as Franchise GRL and regional Regulatory Affairs Director. - GPT Representation and Strategic Influence: 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. - Health Authority Engagement: 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. - External Insight and Policy Shaping: 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. - GRST Leadership and Talent Development: 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. - Data-Driven Governance and Risk Management: 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. - Milestone Delivery and Dossier Excellence: 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. - Innovation and Ways of Working: 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. - Cross-Functional and Regional Partnership: 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. We need to preserve all substantive information; we can put each as

. Essential Skills/Experience: list after "Essential Skills/Experience". Let's extract each bullet (they are sentences separated by periods). The text: "Bachelor 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 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." We'll put each as

. Desirable Skills/Experience: list after "Desirable Skills/Experience". Text: "Master's Degree, PhD or MD in a science related field. Experience with product development in oncology, autoimmune, rare diseases, and neurology across multiple indications and modalities. Experience working on due diligence activities and in a business alliance environment. Experience contributing to external policy, regulatory science, or industry advocacy initiatives." We'll put as

maybe under a "Preferred Qualifications" section, but we only have headings: Requirements, Qualifications, Skills. Could put under Qualifications or Skills. Since we already have Essential Skills/Experience as Requirements, we could put Desirable under Qualifications or Skills. Let's decide: Use "Qualifications" for education and experience requirements (essential) and "Preferred Qualifications" not a listed heading; but we only allowed headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We could put essential under Requirements, desirable under Qualifications or Skills. But we need to avoid duplication. Perhaps we put essential under Requirements, desirable under Qualifications (since they include education and experience). Or we could put essential under Skills, desirable under Qualifications. Let's think: The heading "Skills" is for skills; "Qualifications" for qualifications like degree, years experience. The essential list includes both education/experience and skills. But we can split: Requirements: education and years experience (Bachelor degree + 10+ years). Qualifications: demonstrated success, deep understanding, etc. Skills: leadership, communication, etc. However the instruction: "Prefer a few substantive sections over many thin ones." So maybe better to have just Requirements (essential) and Skills (desirable) or combine. But we need to preserve all info; we can have multiple sections as long as they are substantive. We could have: - About the role (intro) - Responsibilities (accountabilities) - Requirements (essential skills/experience) - Qualifications (desirable skills/experience) - Benefits - Pay - Schedule That seems reasonable. Now Benefits paragraph: "Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans." Also earlier: "In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly roles)." That's more compensation/benefits. Also "Competitive Salary And Benefits Package On Offer" includes salary range. We need to separate Pay and Benefits. Pay: salary range and bonus/equity info. Benefits: retirement, vacation, leaves, health benefits. Let's extract Pay info: "The annual base salary in for this position in the US, ranges from $276,000 - 414,000. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly roles)." We'll put that as

under Pay heading. Benefits: "Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans." Also maybe the earlier sentence about retirement contribution is part of Pay; but we already captured. Now Schedule: paragraph about in-person working: "When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility." We'll put that under Schedule. Now we need to remove boilerplate: At end there is "Join us in our unique and ambitious world. Why AstraZeneca: Here, transformative science meets decisive execution.... Call To Action Step into a role where your regulatory leadership defines the path from discovery to approval—take the lead and shape the future of cell therapy today! Date Posted 24-Sept-2026 Closing Date 29-Sept-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form." These are boilerplate / EEO / call to action / dates. Should be removed. Also "Available locations: NYC, NYGaithersburg, MDBoston, MASouth San Francisco, CASanta Monica, CA" - location info is substantive? Could be considered metadata but not a heading; we could fold into a short

maybe under About the role or as a separate paragraph. The instruction: "Do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short

or drop it." Location is minor metadata; we can include as a short p maybe after