Head of Regulatory Affairs & Medical Writing (VP/SVP)

We need to output HTML fragment with sections: About the role? The posting includes description of role. We need headings:

for section headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We must include sections only when posting has real specific content. We have content for responsibilities (Key Responsibilities). Qualifications (Qualifications). Benefits (Benefits). Pay (Compensation). Possibly About the role: the initial paragraph describing role could be considered About the role. We'll include that as

About the role

with

. Responsibilities: list items. Requirements: maybe not separate; but we have qualifications. Could treat Qualifications as Requirements? The instruction says use headings for those specific labels if content exists. We have Qualifications section. We'll output

Qualifications

with

• for each bullet. Benefits: we have benefits description. Pay: we have salary range. Schedule: not mentioned, so omit. Skills: not explicit separate; could be part of qualifications but we don't have separate Skills heading. We'll not create Skills if no explicit content. Also About the role: we have initial paragraph. We'll include. We must remove boilerplate: EEO, equal opportunity, etc. Also remove duplicated lines, navigation, cookie, legal, application instructions. The posting includes repeated "SystImmune is an Equal Opportunity Employer..." twice; we remove those. Also remove "We offer an opportunity for you to learn and grow while making significant contributions to the company’s success." repeated; we can keep one instance maybe but it's somewhat boilerplate; but it's part of description. Might keep as part of About the role? It's somewhat generic but still substantive? It's repeated; we can keep one occurrence. We'll keep the first occurrence maybe. We need to preserve ALL substantive information; do not invent or summarize away detail. So we need to keep all details from responsibilities, qualifications, benefits, pay. Let's extract: About the role paragraph: "The VP/SVP, Head of Regulatory Affairs will provide strategic and operational leadership for the Company’s global regulatory function and serve as a key member of the leadership team. This individual will be responsible for developing and executing global regulatory strategies across the Company’s oncology portfolio, from early development through registration and lifecycle management. The role will lead interactions with global health authorities, provide regulatory guidance to executive leadership and cross-functional development teams, and build and lead a high-performing Regulatory Affairs and Medical Writing organization." We could also include the sentence about SystImmune description? That's about company, not role. Might be considered About the role? Probably not needed. We'll keep role description. Responsibilities: list under "Key Responsibilities". Items: - Global Regulatory Strategy: Develop and execute integrated global regulatory strategies across the Company’s oncology portfolio, from early development and IND-enabling activities through clinical development, registration, commercialization, and lifecycle management. Ensure regulatory strategies are aligned with corporate and product development objectives. - Clinical Development Strategy: Provide strategic regulatory guidance on clinical development plans, target product profiles, pivotal trial design, registration pathways, and global development sequencing. Partner closely with Clinical Development, Biostatistics, Clinical Operations, CMC, and other functions to optimize development and registration strategies. - Regulatory Submissions & Approvals: Lead and oversee the preparation, submission, and management of major regulatory applications, including INDs, BLAs, MAAs, and other global submissions. Drive regulatory strategy and execution toward timely approvals across key markets. - Health Authority Interactions: Serve as the senior regulatory representative and lead key interactions and negotiations with the FDA, EMA, and other global health authorities, including Pre-IND, End-of-Phase, Type B/C, pre-BLA and other critical regulatory meetings. - Regulatory Risk Management & Intelligence: Proactively identify regulatory risks, opportunities, and evolving requirements; develop mitigation strategies and leverage regulatory intelligence and competitive insights to inform development and business decisions. - Medical Writing Oversight: Provide strategic oversight of Medical Writing activities to ensure high-quality, scientifically rigorous, and timely regulatory and clinical documentation supporting global development and submissions. - Organization & Team Leadership: Build, develop, and lead a high-performing Regulatory Affairs and Medical Writing organization. Establish scalable processes, capabilities, and infrastructure to support the Company’s growing global portfolio while mentoring and developing team members. Qualifications: list: - Advanced degree in life sciences, medicine, pharmacy, or a related field (MD, PhD, PharmD, or equivalent) preferred. - 15+ years of progressive Regulatory Affairs experience within the biotechnology or pharmaceutical industry, including significant experience in senior leadership roles. - Extensive experience in oncology drug development and global regulatory strategy is strongly preferred. - Experience with biologics, antibody-drug conjugates (ADCs), bispecific/multispecific antibodies, or other complex therapeutic modalities is highly desirable. - Demonstrated track record of leading major regulatory submissions, including INDs and preferably successful BLA/MAA filings and approvals. - Extensive experience leading interactions and negotiations with the FDA and other global health authorities, with demonstrated ability to navigate complex regulatory issues and achieve alignment on development and registration strategies. - Strong understanding of clinical development, with demonstrated ability to provide strategic regulatory guidance on clinical development plans, pivotal trial design, registration pathways, expedited development programs, and lifecycle management. - Demonstrated ability to develop and execute integrated global regulatory strategies across the U.S., Europe, China, and other key markets. - Proven experience building, developing, and leading high-performing Regulatory Affairs teams. - Strong scientific and business acumen, with the ability to establish credibility and collaborate effectively with Clinical Development, CMC, Quality, Medical Affairs, Commercial, and other cross-functional stakeholders. - Exceptional leadership, communication, influencing, and problem-solving skills, with strong executive presence and the ability to operate effectively in a fast-paced, entrepreneurial, and global biotechnology environment. Benefits: The posting says: "SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE." We'll put that as
  • items maybe each benefit separated by commas; but we can keep as a single
  • with the list. Better to split: but the instruction: use
    • for any list of duties/requirements/benefits. So we can make each benefit as separate
    • . Let's parse: - 100% paid employee premiums for medical/dental/vision - STD (short-term disability) - LTD (long-term disability) - 401(k) plan with a 50% company match of up to 3% - vesting schedule of only 5 years - 15 PTO days per year - sick leave - 11 paid holidays - MORE (maybe vague; but it's part of benefits; we could keep as "additional benefits" but it's vague; maybe we keep as is.) Pay: "The expected base salary range for this position is $340,000 - $420,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate’s level qualifications, experience, and skills." We'll put that in

      under

      Pay

      . Schedule: not present, omit. We must not repeat job title as heading. Already not. We must not include Job ID/requisition numbers. We must output only HTML fragment. Let's craft:

      About the role

      The VP/SVP, Head of Regulatory Affairs will provide strategic and operational leadership for the Company’s global regulatory function and serve as a key member of the leadership team. This individual will be responsible for developing and executing global regulatory strategies across the Company’s oncology portfolio, from early development through registration and lifecycle management. The role will lead interactions with global health authorities, provide regulatory guidance to executive leadership and cross-functional development teams, and build and lead a high-performing Regulatory Affairs and Medical Writing organization.

      Responsibilities

      • Global Regulatory Strategy: Develop and execute integrated global regulatory strategies across the Company’s oncology portfolio, from early development and IND-enabling activities through clinical development, registration, commercialization, and lifecycle management. Ensure regulatory strategies are aligned with corporate and product development objectives.
      • Clinical Development Strategy: Provide strategic regulatory guidance on clinical development plans, target product profiles, pivotal trial design, registration pathways, and global development sequencing. Partner closely with Clinical Development, Biostatistics, Clinical Operations, CMC, and other functions to optimize development and registration strategies.
      • Regulatory Submissions & Approvals: Lead and oversee the preparation, submission, and management of major regulatory applications, including INDs, BLAs, MAAs, and other global submissions. Drive regulatory strategy and execution toward timely approvals across key markets.
      • Health Authority Interactions: Serve as the senior regulatory representative and lead key interactions and negotiations with the FDA, EMA, and other global health authorities, including Pre-IND, End-of-Phase, Type B/C, pre-BLA and other critical regulatory meetings.
      • Regulatory Risk Management & Intelligence: Proactively identify regulatory risks, opportunities, and evolving requirements; develop mitigation strategies and leverage regulatory intelligence and competitive insights to inform development and business decisions.
      • Medical Writing Oversight: Provide strategic oversight of Medical Writing activities to ensure high-quality, scientifically rigorous, and timely regulatory and clinical documentation supporting global development and submissions.
      • Organization & Team Leadership: Build, develop, and lead a high-performing Regulatory Affairs and Medical Writing organization. Establish scalable processes, capabilities, and infrastructure to support the Company’s growing global portfolio while mentoring and developing team members.

      Qualifications

      • Advanced degree in life sciences, medicine, pharmacy, or a related field (MD, PhD, PharmD, or equivalent) preferred.
      • 15+ years of progressive Regulatory Affairs experience within the biotechnology or pharmaceutical industry, including significant experience in senior leadership roles.
      • Extensive experience in oncology drug development and global regulatory strategy is strongly preferred.
      • Experience with biologics, antibody-drug conjugates (ADCs), bispecific/multispecific antibodies, or other complex therapeutic modalities is highly desirable.
      • Demonstrated track record of leading major regulatory submissions, including INDs and preferably successful BLA/MAA filings and approvals.
      • Extensive experience leading interactions and negotiations with the FDA and other global health authorities, with demonstrated ability to navigate complex regulatory issues and achieve alignment on development and registration strategies.
      • Strong understanding of clinical development, with demonstrated ability to provide strategic regulatory guidance on clinical development plans, pivotal trial design, registration pathways, expedited development programs, and lifecycle management.
      • Demonstrated ability to develop and execute integrated global regulatory strategies across the U.S., Europe, China, and other key markets.
      • Proven experience building, developing, and leading high-performing Regulatory Affairs teams.
      • Strong scientific and business acumen, with the ability to establish credibility and collaborate effectively with Clinical Development, CMC, Quality, Medical Affairs, Commercial, and other cross-functional stakeholders.
      • Exceptional leadership, communication, influencing, and problem-solving skills, with strong executive presence and the ability to operate effectively in a fast-paced, entrepreneurial, and global biotechnology environment.

      Benefits

      • 100% paid employee premiums for medical/dental/vision
      • STD (short-term disability)
      • LTD (long-term disability)
      • 401(k) plan with a 50% company match of up to 3%
      • Vest