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Aerogen Pharma - SVP Regulatory Affairs and Quality Assurance Officer
About Aerogen Pharma
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.
What is the role?
The SVP Regulatory Affairs and Quality Assurance Officer will guide Aerogen Pharma’s Regulatory and Quality strategies and organizational development, providing Regulatory filing expertise in all phases of development. You will develop, implement, and ensure compliance with the overall Aerogen Pharma quality systems.
You will be a contributing member of Aerogen Pharma’s management team. Reporting to the Aerogen Pharma CEO, you will be responsible for an array of activities across the Regulatory Affairs Quality Assurance and Control organisation.
Duties and Responsibilities
Regulatory Affairs
• Develop and implement robust regulatory strategy for drug/device combination biologics products
• Provide operational support across all clinical programs, while adhering to applicable US and ex-US regulatory, compliance, and quality standards
• Build and drive Regulatory department/function by providing expert strategic insights and solutions toward successful product approvals
• Develop and implement robust regulatory strategy and provide operational support across all clinical programs, while adhering to applicable US and ex-US regulatory, compliance, and quality standards
• Prepare and deliver successful submissions/filings and outcomes with global health authorities (US, EU, China, Japan) by providing effective leadership, oversight, direction, and planning
• Develop timelines, milestones, and budgets to track progress, identify risks/constraints, and propose effective solutions for clinical programs
• Prepare and contribute to reports and regulatory submissions, including identification and mitigation of potential critical issues, regulatory risks, to support decision-making on all product candidates
• Work cross-functionally with various teams (CMC, Clinical, external consultants, etc.) to ensure regulatory plans are established and align with company objectives
Quality Control and Assurance
• Develop, implement, and maintain robust quality management systems, to ensure compliance with GCP and GMP requirements for device, drug substance and drug product through all phases of development
• Oversee and manage the quality assurance department (team of 6 – 8), ensuring compliance with all applicable regulations and guidelines, such as cGMP, ICH, and FDA requirements
• Collaborate with cross-functional teams, both internal and with external CDMOs to ensure the quality and consistency of biologics throughout the product lifecycle
• Establish and monitor key quality metrics, identify areas for improvement, and implement corrective and preventive actions
• Provide strategic guidance and supervision in quality-related decision-making, risk management, and quality culture development
Education and Experience
• PhD or equivalent in medical or related scientific field
• Significant experience (> 15 years) in regulatory affairs, with recent experience with product Phase 3 and BLA/NDA filing
• Extensive experience in drug, device and drug/device combination regulatory filings (510Ks and IND/NDA/BLA)
• Demonstrated strategic capability and ability to see the overall, 'big' picture, along with examples of showing bravery and confidence to drive and implement change
• Thorough understanding of the FDA (biologics division), including experience in PAI readiness
• Results oriented. Strong initiative, accountability, and willingness to take ownership and drive projects to completion
• Minimum of 10 years of progressive experience in quality assurance, preferably in the biopharmaceutical or biologics industry
• Demonstrated expertise in the design, implementation, and management of quality systems for the development, manufacturing, and release of biological products
• In-depth knowledge of relevant regulations, guidelines, and best practices governing the quality assurance of biologics, including FDA, cGMP, and ICH requirements
• Proven record of accomplishment of leading and managing a quality assurance team, with a strong focus on continuous improvement and fostering a culture of quality
• Results oriented. Strong initiative, accountability, and willingness to take ownership and drive projects to completion
Why Aerogen Pharma
As a key member of Aerogen Group, the global market leader in high performance aerosol drug delivery, Aerogen Pharma is at a pivotal point in the company's life cycle. With plans to expand and centralise our US hubs over the next two years, we offer an environment where you can thrive professionally and learn from driven industry leaders in drug development and commercialization, inhaled devices, and neonatology.
We foster an inclusive culture that empowers you to contribute to the transformation of Neonatal care, where potential is recognised and professional development is encouraged.
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.
What is the role?
The SVP Regulatory Affairs and Quality Assurance Officer will guide Aerogen Pharma’s Regulatory and Quality strategies and organizational development, providing Regulatory filing expertise in all phases of development. You will develop, implement, and ensure compliance with the overall Aerogen Pharma quality systems.
You will be a contributing member of Aerogen Pharma’s management team. Reporting to the Aerogen Pharma CEO, you will be responsible for an array of activities across the Regulatory Affairs Quality Assurance and Control organisation.
Duties and Responsibilities
Regulatory Affairs
• Develop and implement robust regulatory strategy for drug/device combination biologics products
• Provide operational support across all clinical programs, while adhering to applicable US and ex-US regulatory, compliance, and quality standards
• Build and drive Regulatory department/function by providing expert strategic insights and solutions toward successful product approvals
• Develop and implement robust regulatory strategy and provide operational support across all clinical programs, while adhering to applicable US and ex-US regulatory, compliance, and quality standards
• Prepare and deliver successful submissions/filings and outcomes with global health authorities (US, EU, China, Japan) by providing effective leadership, oversight, direction, and planning
• Develop timelines, milestones, and budgets to track progress, identify risks/constraints, and propose effective solutions for clinical programs
• Prepare and contribute to reports and regulatory submissions, including identification and mitigation of potential critical issues, regulatory risks, to support decision-making on all product candidates
• Work cross-functionally with various teams (CMC, Clinical, external consultants, etc.) to ensure regulatory plans are established and align with company objectives
Quality Control and Assurance
• Develop, implement, and maintain robust quality management systems, to ensure compliance with GCP and GMP requirements for device, drug substance and drug product through all phases of development
• Oversee and manage the quality assurance department (team of 6 – 8), ensuring compliance with all applicable regulations and guidelines, such as cGMP, ICH, and FDA requirements
• Collaborate with cross-functional teams, both internal and with external CDMOs to ensure the quality and consistency of biologics throughout the product lifecycle
• Establish and monitor key quality metrics, identify areas for improvement, and implement corrective and preventive actions
• Provide strategic guidance and supervision in quality-related decision-making, risk management, and quality culture development
Education and Experience
• PhD or equivalent in medical or related scientific field
• Significant experience (> 15 years) in regulatory affairs, with recent experience with product Phase 3 and BLA/NDA filing
• Extensive experience in drug, device and drug/device combination regulatory filings (510Ks and IND/NDA/BLA)
• Demonstrated strategic capability and ability to see the overall, 'big' picture, along with examples of showing bravery and confidence to drive and implement change
• Thorough understanding of the FDA (biologics division), including experience in PAI readiness
• Results oriented. Strong initiative, accountability, and willingness to take ownership and drive projects to completion
• Minimum of 10 years of progressive experience in quality assurance, preferably in the biopharmaceutical or biologics industry
• Demonstrated expertise in the design, implementation, and management of quality systems for the development, manufacturing, and release of biological products
• In-depth knowledge of relevant regulations, guidelines, and best practices governing the quality assurance of biologics, including FDA, cGMP, and ICH requirements
• Proven record of accomplishment of leading and managing a quality assurance team, with a strong focus on continuous improvement and fostering a culture of quality
• Results oriented. Strong initiative, accountability, and willingness to take ownership and drive projects to completion
Why Aerogen Pharma
As a key member of Aerogen Group, the global market leader in high performance aerosol drug delivery, Aerogen Pharma is at a pivotal point in the company's life cycle. With plans to expand and centralise our US hubs over the next two years, we offer an environment where you can thrive professionally and learn from driven industry leaders in drug development and commercialization, inhaled devices, and neonatology.
We foster an inclusive culture that empowers you to contribute to the transformation of Neonatal care, where potential is recognised and professional development is encouraged.
Location
Pharma USA
Pharma USA
Department
QA/RA
QA/RA
Job Title
Aerogen Pharma - SVP Regulatory Affairs and Quality Assurance Officer
Aerogen Pharma - SVP Regulatory Affairs and Quality Assurance Officer
Salary
Experience
City
San Mateo, California
San Mateo, California
Country
USA
USA
