THE COMPANY
89bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases. The company’s lead product candidate, pegozafermin (BIO89-100), is a specifically engineered glycoPEGylated analog of FGF21. Pegozafermin is being developed for the treatment of nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). 89bio is headquartered in San Francisco with operations in Herzliya, Israel.
THE ROLE
Reporting to the Vice President of Regulatory Affairs, the Senior Manager, Regulatory Affairs will function as the internal regulatory expert and point of contact on Clinical Study Teams and in coordination across the Regulatory function.
THE RESPONSIBILITIES
· To be the internal regulatory expert and point of contact on Clinical Study Teams and in coordination across the Regulatory function.
· Responsibilities include Clinical Trial Applications, IND Information Amendments, responses to regulatory requests, regulatory project management (establishment of timelines and coordination to meet deadlines), regulatory operations, regulatory writing.
· Contribution to and execution of regulatory strategy for drug development in alignment with company goals.
· Excellent technical writing skills and attention to detail.
· Ability to read, analyze, and interpret scientific, technical data, and regulatory guidelines and regulations.
· Track queries with regulatory agencies, provide written responses to queries, and provide status updates.
· Perform research for regulatory strategy development for clinical development projects.
· Collaborate with project teams to ensure standards and protocols are followed.
· Ensure regulatory submissions follow the project timeline.
THE QUALIFICATIONS
· MA Chemistry.
· 7+ years in regulatory affairs product development.
THE PERKS
· Competitive health insurance coverage
·$150/ monthly non-taxable remote work stipend
· Generous PTO allowance
· 401k match
· Employee Stock Purchase Plan (ESPP)
· Commuter Benefits
· Women’s forum / mentoring
· Office based in the heart of San Francisco, near plenty of shops and restaurants
· Fun opportunities to engage with co-workers in-person and remotely
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability. Proof of COVID vaccination is a condition of employment.