Senior Director, Regulatory Affairs
Location: South San Francisco, California, United States
In this role, you will be the Global Regulatory Lead for investigational hepatitis B virus (HBV) programs (as assigned) and will prepare and/or oversee regulatory activities in support of corporate objectives. In collaboration with other functional area leads, develop and execute the regulatory strategy as defined in the integrated development plan. The Senior Director will lead the regulatory subteam for the assigned assets and will provide ongoing strategic regulatory advice at various forums, including the development core team and clinical, nonclinical, and CMC subteams. The Senior Director will also provide leadership for the implementation of a Regulatory Information management system and participate in cross-functional teams supporting other system implementation as needed.
- Lead regulatory activities for assigned investigational hepatitis B programs, ensuring alignment with ICH and regional requirements
- Provide strategic regulatory contributions in the development and ongoing review of integrated project development plans
- Prepare and/or oversee submissions to support project development plans
- Maintain broad knowledge of regulatory requirements, particularly for the US, including clinical, nonclinical, submission, and compliance aspects of regulatory affairs
- Lead efforts to design and implement a Regulatory Information Management system to meet the needs of the business
- Science degree (PhD, PharmD, MD, MSc) with a minimum of 12+ years of experience in regulatory affairs
- Experience as a global regulatory lead managing investigational products
- Demonstrated effective verbal and written communication, negotiation and interpersonal skills
- Extensive knowledge of regulatory requirements, including ICH requirements
- Strong track record in a fast-paced and nimble environment
- Experience in antiviral drug development is a plus
About Assembly Bio
Assembly Biosciences (NASDAQ: ASMB) is a clinical-stage biotechnology company developing innovative therapeutics targeting hepatitis B virus (HBV) and diseases associated with the microbiome. The HBV program is focused on advancing a new class of potent, oral core inhibitors that have the potential to increase cure rates for chronically infected patients. The microbiome program is developing novel oral live microbial biotherapeutic candidates with Assembly Bio’s fully integrated platform, including a robust process for strain identification and selection, GMP banking and production, and targeted delivery to the lower gastrointestinal tract with the GEMICEL® technology.
We believe our Microbiome platform represents a best in class approach to developing biopharmaceutical agents from live biotherapeutic products. ABI-M201, our lead program in mildly to moderately active ulcerative colitis (UC), is currently in a phase 1b clinical trial. This program is part of a broader collaboration we established with Allergan in 2017 for gastrointestinal programs such as UC, Crohn’s disease and Irritable Bowel Syndromes. Our internal pipeline comprises first in class or best in class live microbial biotherapeutic approaches in areas such as oncology, immune mediated and metabolic disorders, and other areas of high medical need.
We pride ourselves on creating a culture and work environment that is scientifically driven, ambitious, and collaborative. We encourage diversity of thought that leads to great innovation and are looking to add to our dynamic team of great people who are driven to transform the lives of patients.
Assembly Bio is headquartered in Carmel, Indiana, while the R&D headquarters is in South San Francisco. The Company also has a microbiome manufacturing facility in Groton, CT, and offices in China. Assembly Bio has a strong balance sheet having raised approximately $166 million in July 2018. We are positioned well to build the next phase of the Company toward global development and commercialization of our innovative medicines in HBV-cure and the Microbiome.
Assembly Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. We are committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
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