Senior Director, Global Regulatory Affairs
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we need to map content to those headings. "About Aerogen Pharma" is not exactly "About the role". Could we treat it as "About the role"? The instruction: Use for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It says e.g., not limited to those? It says use for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Likely they expect those exact headings if applicable. We have content: About the company (Aerogen Pharma) maybe could go under "About the role"? But "About the role" would be description of role, not company. However we have "What is the role?" which describes role. That could be "About the role". Then responsibilities: "What are the key responsibilities?" -> Responsibilities. Education and experience: "What education and experience are required?" -> Requirements or Qualifications? Typically Requirements = education and experience. Qualifications could be similar. We'll put under Requirements. Skills: "What key skills will make you great at the role?" -> Skills. Why Join Aerogen Pharma: maybe could be Benefits? But it's not benefits; it's motivation. Could be omitted if not matching allowed headings. However we could treat as "Benefits"? Not exactly. The instruction: include a section ONLY when the posting has real, specific content for it — never emit a heading followed by filler/placeholder text. So we should only include sections that match content. If we don't have Benefits, Pay, Schedule, we omit them. So we will include: About the role, Responsibilities, Requirements, Skills. Possibly also Qualifications? But we have education and experience under Requirements; we could also have Qualifications separate but content overlaps. Better to not duplicate. We'll follow: About the role (from "What is the role?" plus company description? Actually company description is separate; maybe we could include a brief "About Aerogen Pharma" as a paragraph before sections? The instruction: do NOT repeat the job title as a heading (the page already shows it) and do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Likely they expect those exact headings if applicable. We have content: About the company (Aerogen Pharma) maybe could go under "About the role"? But "About the role" would be description of role, not company. However we have "What is the role?" which describes role. That could be "About the role". Then responsibilities: "What are the key responsibilities?" -> Responsibilities. Education and experience: "What education and experience are required?" -> Requirements or Qualifications? Typically Requirements = education and experience. Qualifications could be similar. We'll put under Requirements. Skills: "What key skills will make you great at the role?" -> Skills. Why Join Aerogen Pharma: maybe could be Benefits? But it's not benefits; it's motivation. Could be omitted if not matching allowed headings. However we could treat as "Benefits"? Not exactly. The instruction: include a section ONLY when the posting has real, specific content for it — never emit a heading followed by filler/placeholder text. So we should only include sections that match content. If we don't have Benefits, Pay, Schedule, we omit them. So we will include: About the role, Responsibilities, Requirements, Skills. Possibly also Qualifications? But we have education and experience under Requirements; we could also have Qualifications separate but content overlaps. Better to not duplicate. We'll follow: About the role (from "What is the role?" plus company description? Actually company description is separate; maybe we could include a brief "About Aerogen Pharma" as a paragraph before sections? The instruction: do NOT repeat the job title as a heading (the page already shows it) and do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short
or drop it. It didn't forbid a general intro paragraph before headings. So we can include a
with the company description (About Aerogen Pharma) before the sections. Then sections. We must preserve ALL substantive information; do not invent or summarize away detail. So we need to include all details from the posting, except boilerplate (EEO, etc). Also remove duplicated lines, cookie/navigation/legal/EEO etc. So we need to copy the text exactly? Not necessarily exact wording but preserve all substantive info. We'll produce paragraphs and lists. Let's extract content: Company description: "Aerogen Pharma is a US based clinical-stage specialty pharmaceutical company with a mission to develop inhaled drug/biologic and device combination that will transform the standard of care for acute and critically ill patients. Our goal is to create medically superior, proprietary and commercially differentiated combination products by combining proven therapeutic molecules with a unique, high-performance aerosol delivery system. We are embarking on an exciting and dynamic stage in our combination product development, moving into phase 3 clinical trial for one of the biggest breakthroughs in Neonatal care. We are a team of passionate industry experts who are leading, shaping, and driving a potentially transformative medical breakthrough for the treatment of neonatal respiratory distress syndrome (RDS) in the developed world. Additionally, in partnership with The Bill & Melinda Gates Foundation, we have an ambitious program in development to bring low-cost surfactant to the millions of premature babies with RDS born each year. Join us as we embark on this breakthrough and become inspired to deliver." Role description (What is the role?): "Aerogen Pharma is seeking an experienced global regulatory leader to serve as the strategic deputy to the Senior Vice President of Regulatory Affairs and assume direct accountability for some of the company’s priority development programs. The successful candidate will be the accountable regulatory leader for programs, shape company-level development decisions, and help build Aerogen Pharma’s future regulatory organization.The position offers unusual breadth and visibility:• Lead US, EU, China, and rest-of-world registration strategy for a late-stage drug-device combination product.• Build an innovative regulatory strategy for an early-stage medicine intended for low- and middle-income countries.• Work directly with the SVP of Regulatory Affairs, executive leadership, development teams, and external business partners.• Influence clinical development, global access, commercialization, and portfolio strategy.• Serve as the primary regulatory decision-maker for assigned programs.• Help establish the capabilities, operating model, and future structure of Aerogen Pharma’s regulatory organization.The role is designed for a regulatory leader who wants meaningful product ownership, broad organizational influence, and a credible path to expanded executive leadership." Key responsibilities (What are the key responsibilities?): List items under headings: Regulatory and Organizational Leadership, Late-Stage Drug-Device Combination Product, Global-Access Drug Development Program. We need to preserve all bullet points. Let's copy them exactly as in text: Regulatory and Organizational Leadership • Serve as the accountable global regulatory leader for multiple development programs. • Act as a strategic deputy and trusted advisor to the Senior Vice President of Regulatory Affairs. • Represent Regulatory Affairs on cross-functional development, governance, and portfolio teams. • Translate corporate and product-development objectives into integrated global regulatory strategies, plans, timelines, and resource requirements. • Identify regulatory risks, opportunities, and critical decision points early and develop practical mitigation and contingency plans. • Manage regulatory consultants, vendors, regional representatives, and business partners. • Mentor regulatory team members and help build the future regulatory organization. • Establish fit-for-purpose regulatory processes, governance practices, and operating standards appropriate for a growing pharmaceutical company. • Promote a culture of accountability, transparency, constructive challenge, and regulatory excellence. Late-Stage Drug-Device Combination Product • Lead and execute global regulatory strategy for a late-stage drug-device combination product. • Develop and execute the strategy for marketing authorization in the European Union and additional rest-of-world markets. • Integrate medicinal-product, device, combination-product, human-factors, usability, manufacturing, labeling, and quality requirements into a unified regulatory strategy. • Lead interactions with the European Medicines Agency, national competent authorities, notified bodies, and other relevant regulatory organizations. • Assess the impact of regulatory developments on Aerogen Pharma’s programs, timelines, and business strategy. • Develop the regulatory strategy for approval in China in collaboration with Aerogen Pharma’s business partner. • Lead the preparation for and attendance at regulatory authority meetings including responses to questions • Support regulatory inspections, approval readiness, and launch preparation. • Support global lifecycle-management planning, including indication expansion, labeling changes, device modifications, and post-approval obligations. Global-Access Drug Development Program • Lead global regulatory strategy for an early-stage drug product intended for low- and middle-income countries. • Build an integrated regulatory roadmap that advances global-access objectives. • Engage with regulatory authorities, global health organizations, development partners, foundations, and other external stakeholders. Education and experience required: • Bachelor’s degree in a scientific, medical, engineering, or related discipline. • Advanced degree such as an MS, PharmD, PhD, MD, or equivalent is preferred. • 10 or more years of progressively responsible regulatory affairs experience in the pharmaceutical, biotechnology, or combination-product industry. • Demonstrated experience independently leading global regulatory strategy for a development-stage product. • Experience leading or making a significant contribution to a major marketing application, such as an MAA, NDA, BLA, or equivalent submission. Key skills: • Demonstrated ability to lead complex cross-functional initiatives in a matrixed organization. • Strong strategic judgment and the ability to provide clear, independent recommendations to senior leaders. • Excellent written, verbal, and executive communication skills. • Ability to operate effectively in a small, fast-paced company and move comfortably between high-level strategy and hands-on execution. Why Join Aerogen Pharma: "This role provides the opportunity to shape the global development and approval strategy for multiple differentiated programs with the potential to meaningfully improve patient outcomes. The successful candidate will have direct access to executive leadership, substantial authority over assigned programs, and a central role in building Aerogen Pharma’s future regulatory capabilities.The position combines the challenge of preparing a late-stage drug-device combination product for global commercialization with the opportunity to create an innovative regulatory pathway intended to bring an important medicine first to patients in low- and middle-income countries.For the right individual, this is a career-defining opportunity to assume broad product ownership, influence enterprise strategy, and grow into expanded regulatory leadership." Location and Relocation: "This position is based in Research Triangle Park, North Carolina, with a flexible hybrid work model requiring on site presence at least 3 days/week. Relocation assistance available as necessary." We need to decide where to put Location and Relocation. Could be under Schedule? Not exactly. Could be under Benefits? Not exactly. Could be its own section but not in allowed headings. The instruction: use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It says e.g., implying those are examples but we could also use other headings? It says use for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Likely they expect only those headings. However they also say "include a section ONLY when the posting has real, specific content for it — never emit a heading followed by filler/placeholder text". So if we have content for Location and Relocation, we need a heading. But none of the example headings match. Could we treat Location and Relocation as "Schedule"? Not really. Could treat as "Benefits"? Relocation assistance could be a benefit. But the section also includes location and hybrid work model. Could be considered "Schedule"? Hybrid work model requiring on site presence at least 3 days/week is schedule info. Relocation assistance is a benefit. Might be split. But we could create a "Schedule" section for the hybrid work model, and a "Benefits" section for relocation assistance. However the instruction says prefer a few substantive sections over many thin ones. Might be okay to combine location and relocation under a heading like "Location and Relocation" but that's not in the list. Might be considered okay if we follow the pattern: they gave examples but not exclusive. The instruction: "Use for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." The "e.g." suggests those are examples, not an exhaustive list. So we can use other headings as needed, as long as they are . So we can use "Location and Relocation". Good.
We must not include boilerplate: Equal Employment Opportunity etc. Remove.
Now produce HTML fragment: start with a
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." The "e.g." suggests those are examples, not an exhaustive list. So we can use other headings as needed, as long as they are . So we can use "Location and Relocation". Good.
We must not include boilerplate: Equal Employment Opportunity etc. Remove.
Now produce HTML fragment: start with a
for company description. Then
About the role
withcontaining role description (including the bullet list? Actually the bullet list under "What is the role?" includes the visibility bullets. Those are part of role description. So we should include them as a
- under that section. The role description paragraph plus the bullet list.
Thus: