Senior Director, Regulatory Affairs

Assembly Biosciences, Inc. San Francisco , CA 94118

Posted 3 months ago


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.

Key Responsibilities:

  • 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

Preferred Qualifications:

  • 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.

AAP/EEO Statement

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.

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Senior Director Regulatory Affairs

Seattle Genetics

Posted 3 weeks ago

VIEW JOBS 1/29/2020 12:00:00 AM 2020-04-28T00:00 Summary: The Sr. Director, Regulatory Affairs provides strategic regulatory leadership and oversight in support of multiple early and late phase development programs at Seattle Genetics. This includes oversight of the development and implementation of global regulatory strategies, ensuring timely preparation, review and submission of documents to regulatory authorities, oversight of the preparation of meeting requests and briefing documents to obtain regulatory advice, collaborating with development partners, and maintaining compliance with applicable regulatory requirements. The successful candidate will serve as a resource to team members for the regulatory requirements, processes, and logistics to conduct global drug development activities for compounds from the preclinical stage through the initial marketing application, and ultimately life cycle management. Responsibilities: * Oversee the development and implementation of regulatory strategies by global regulatory leads and regional regulatory leads * Provide regulatory guidance and strategy including identifying and assessing regulatory risks * Define strategy and review submissions to regulatory authorities including FDA, EMA and other national authorities to support the conduct of clinical trials and approval of marketing applications (IND, CTA, BLA/NDA, MAA, etc) * Collaborate with global development partners * Oversee development and presentation of development strategies for governance milestones * Support Ex-US regulatory expansion initiatives * Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programs * Oversee the preparation of meeting requests and briefing documents, and the coordination and preparation of teams for health authority meetings * Manage, train and mentor regulatory affairs personnel Requirements: * MD, PhD or PharmD in a scientific discipline preferred along with 10+ years of experience in Regulatory Affairs * BS/MS requires at least 15 years of relevant experience in Regulatory Affairs * Oncology experience required * Knowledge and understanding of global regulations and guidelines * Previous experience in the preparation and submission of regulatory documents * Previous experience in attending and leading a team to prepare for major health authority interactions (e.g. FDA pre-NDA/BLA, EOP2 meetings, advisory committee meetings and/or EU oral explanations/scientific advice, etc.) * Experience with investigational drugs, including late stage development, and marketed products * Ability to work in a cross-functional team environment * Prior managerial experience, with direct supervision of mid- to senior-level regulatory professionals, is highly desirable * Strong attention to detail and the ability to handle multiple tasks * Excellent organizational, computer and documentation skills and an ability to prioritize effectively * Strong interpersonal skills including verbal and written communication As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. #LI-TC1 Seattle Genetics South San Francisco CA

Senior Director, Regulatory Affairs

Assembly Biosciences, Inc.