Astellas Pharma Director, Regulatory Affairs & Quality in Seattle, Washington
Universal Cells is focused on the development and commercialization of stem cell and regenerative medicine therapies. We conduct clinical-grade gene editing of stem cells and have a major effort in R&D. We design and produce stem cells that avoid rejection, and we engineer cells with improved therapeutic properties, all through our world-class gene editing platform.
Our goal is to provide cells for regenerative medicine applications that can treat all patients. Through internal R&D and our corporate partnerships, we are pursuing a diverse range of disease indications, including blindness, cancer, vascular insufficiency, and autoimmune diseases.
Universal Cells (UCI) is announcing a Director, Regulatory Affairs opportunity at their facility in Seattle, WA.
The Director of Regulatory Affairs will be responsible for ensuring product requirements, and applicable regulatory and quality requirements are determined and met through the establishment of the appropriate priorities, objectives, resources, organizational structure, communication, policies and procedures. This position provides leadership and direction for product development through effective quality assurance systems and processes; development and implementation of CMC regulatory strategies; and coordination of regulatory submissions with collaboration partners and Astellas affiliate locations. The primary purpose of this position is to drive regulatory activities, supporting the development and commercialization of Universal Cell's products.
Universal Cells is a wholly-owned subsidiary of Astellas Pharma. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's health around the world through the provision of innovative and reliable pharmaceutical products.
Essential Job Responsibilities:
- Participates on Universal Cells (UCells) Executive Leadership team and defines future state process and business requirements to support strategic initiatives and corporate objectives.
- Provides strategic guidance regarding global regulatory requirements to UCells management team for all CMC regulatory matters in support of UCells product development.
- Acts as the primary regulatory representative at internal meetings as well as at meetings with business partners and regulatory agencies for all UCells CMC related issues.
- Assesses and communicates regulatory requirements to ensure all development activities comply with applicable regulations and guidelines.
- Maintains overall responsibility for the Quality function including the development, implementation and maintenance of quality systems. Interprets regulatory guidelines; anticipates regulatory concerns and integrates changes as needed to ensure compliance.
- Provides leadership in the execution of the UCells Quality Systems activities and execution of the programs and processes related to Document Control, CAPA, Product Disposition, Management Reviews, audits and training activities.
- Collaborates with Cell Editing team and R&D to develop and deliver robust procedures and processes for efficient quality oversight of processes. Ensures all required assessments and testing methods are carried out in support of the UCells Quality Management System.
- Drives key strategic/simplification initiatives taking into consideration UCells business needs, critical success factors and planned timelines for product development.
- Provides creative and innovative solutions while being an advocate for compliance.
- Collaborates with partners and Astellas affiliate locations to compile, review, and submit CMC applications, amendments, and supplements, as needed.
- May serve as a liaison to Contract Manufacturing Organizations (CMO) to obtain supporting CMC documentation required for regulatory submissions.
- Ensures compliance with reporting requirements, including annual and periodic reports, as needed.
- Researches and disseminates regulatory intelligence on trends in US regulatory affairs in the CMC biologics space and industry standards for CMC Regulatory work.
- Complies with Astellas values, ethics & compliance, code of conduct, policies, and best practices, with a commitment to safety in the workplace, valuing of diversity, and promotion of a harassment-free environment.
- BS or advance degree in Life Sciences with 15+ years relevant experience
- 10+ years of direct experience in Regulatory Affairs with a minimum of 4 years in Manufacturing and Control (CMC) regulatory environment.
- Broad experience in product development, regulatory compliance, quality systems and at least 3 years of direct or matrix management experience.
- Prior experience within other functional areas is desirable; prior experience in developing/leading quality systems is required.
- Ability to thrive and flourish in an entrepreneurial early stage company environment that requires "hands-on" implementation, optimal use of limited resources and an ability to work closely with others in a small team setting.
- Ability to work with the management team and regulatory authorities to meet company objectives and initiatives while dealing with rapidly changing regulatory environment.
- Ability to foster and balance a culture of compliance within a culture of innovation
- Strategic thinking; Ability to influence without authority, in a matrix environment
- Exerts influence in the development of overall objectives and long-range goals of the organization.
- Strong time-management and organizational skills coupled with a sense of urgency and strong work ethic.
- Must have critical thinking skills, robust technical writing skills, strong scientific skills, good interpersonal communication skills.
- Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
- Collaborative team player who has the ability to think and act quickly and identify creative solutions to complex problems
- Strong attention to detail with the ability to articulate quality related risks and potential impact.
- Leadership skills, and ability to inspire colleagues
- Proficient knowledge of MS Word, Excel, PowerPoint & Outlook.
- Experience working in cell therapy development highly preferred
- Pharmaceutical product development and manufacturing experience is preferred
- Experience managing projects and teams highly preferred
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Category Regulatory Affairs