89bio
89bio is a clinical-stage biopharmaceutical company dedicated to the development of best-in-class therapies for patients with liver and cardiometabolic diseases who lack optimal treatment options.
The company is focused on rapidly advancing its lead candidate, pegozafermin, through Phase 3 clinical development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG).
THE ROLE
89bio is seeking an exceptional regulatory strategy leader as Regulatory Affairs Director, to join our team and advance our mission to deliver innovative therapies for treatment of liver and cardiometabolic diseases. The Director will be responsible for developing and managing all aspects of the assigned clinical regulatory strategy activities in close collaboration with internal and external stakeholders. THE RESPONSIBILITIES
Regulatory Strategy: Collaborate with the leadership and cross-functional teams to define clinical regulatory strategies and lead their implementation. Lead interactions with global Health Authorities, including FDA, EMA, MHRA, PMDA and others, as needed, by developing strategy and briefing documents, preparing for, and leading agency meetings. Regulatory Submissions: Oversee the preparation of and ensure accuracy, completeness, and timeliness of high-quality submissions to US FDA and global health authorities including original and supplemental BLAs, MAAs, INDs, IND amendments, annual reports, special designations (orphan, breakthrough, PRIME, fast track), responses to Health Authority queries, and pediatric study plans. Cross-functional Collaboration: Represent the Regulatory department in project and study teams and support development teams in interpreting and applying regulations and guidance documents. Regulatory Intelligence, Compliance, and Operational Excellence: Maintain knowledge of current global regulations and regulatory guidance. Implement and maintain regulatory affairs practices and procedures appropriate to support the company’s development stage. Ensure regulatory compliance of global GxP activities. Perform other duties as assigned to support the success of the team and organization. THE QUALIFICATIONS
Bachelor’s degree required; advanced degree in scientific/life-sciences or related field preferred. 10+ years of pharmaceutical industry experience including direct regulatory affairs experience with increasing responsibility. Demonstrated experience authoring and overseeing compilation of regulatory dossiers for global. Ability to travel to SF office 2 times per week or as travel policy requires. Demonstrated experience preparing global regulatory submissions for drug or biologic (protein therapeutics) products (INDs, NDA/BLAs, MAAs). Comprehensive knowledge and understanding of global regulations and guidelines (nonclinical, clinical, labeling, promotional, combination products). Strong project and time management skills to drive multiple ongoing projects simultaneously. Meticulous with strong scientific foundation and critical thinking skills. Excellent interpersonal skills enabling productive cross-functional collaboration with internal and external stakeholders. Ability to author clear, concise, data-driven, and audience-focused regulatory documents. Ability to think creatively and to adapt to new information or changing priorities. SALARY & LEVEL
89bio considers a range of factors when determining salary and level. The expected salary range for this position based on the primary location for this position in Northern California is $200,000 – $250,000. THE PERKS
Competitive health insurance coverage 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 CONDITIONS OF EMPLOYMENT
Background investigations are required for all positions by 89bio, consistent with applicable law. Candidates must already hold work authorization, as visa sponsorship is not available for this role. 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 based on disability. 89bio is committed to the full inclusion of all qualified individuals. As part of this commitment, 89bio will ensure that persons with disabilities are provided reasonable accommodations for the hiring process, and/or to perform essential job functions where the requested accommodation does not impose an undue hardship.
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89bio is seeking an exceptional regulatory strategy leader as Regulatory Affairs Director, to join our team and advance our mission to deliver innovative therapies for treatment of liver and cardiometabolic diseases. The Director will be responsible for developing and managing all aspects of the assigned clinical regulatory strategy activities in close collaboration with internal and external stakeholders. THE RESPONSIBILITIES
Regulatory Strategy: Collaborate with the leadership and cross-functional teams to define clinical regulatory strategies and lead their implementation. Lead interactions with global Health Authorities, including FDA, EMA, MHRA, PMDA and others, as needed, by developing strategy and briefing documents, preparing for, and leading agency meetings. Regulatory Submissions: Oversee the preparation of and ensure accuracy, completeness, and timeliness of high-quality submissions to US FDA and global health authorities including original and supplemental BLAs, MAAs, INDs, IND amendments, annual reports, special designations (orphan, breakthrough, PRIME, fast track), responses to Health Authority queries, and pediatric study plans. Cross-functional Collaboration: Represent the Regulatory department in project and study teams and support development teams in interpreting and applying regulations and guidance documents. Regulatory Intelligence, Compliance, and Operational Excellence: Maintain knowledge of current global regulations and regulatory guidance. Implement and maintain regulatory affairs practices and procedures appropriate to support the company’s development stage. Ensure regulatory compliance of global GxP activities. Perform other duties as assigned to support the success of the team and organization. THE QUALIFICATIONS
Bachelor’s degree required; advanced degree in scientific/life-sciences or related field preferred. 10+ years of pharmaceutical industry experience including direct regulatory affairs experience with increasing responsibility. Demonstrated experience authoring and overseeing compilation of regulatory dossiers for global. Ability to travel to SF office 2 times per week or as travel policy requires. Demonstrated experience preparing global regulatory submissions for drug or biologic (protein therapeutics) products (INDs, NDA/BLAs, MAAs). Comprehensive knowledge and understanding of global regulations and guidelines (nonclinical, clinical, labeling, promotional, combination products). Strong project and time management skills to drive multiple ongoing projects simultaneously. Meticulous with strong scientific foundation and critical thinking skills. Excellent interpersonal skills enabling productive cross-functional collaboration with internal and external stakeholders. Ability to author clear, concise, data-driven, and audience-focused regulatory documents. Ability to think creatively and to adapt to new information or changing priorities. SALARY & LEVEL
89bio considers a range of factors when determining salary and level. The expected salary range for this position based on the primary location for this position in Northern California is $200,000 – $250,000. THE PERKS
Competitive health insurance coverage 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 CONDITIONS OF EMPLOYMENT
Background investigations are required for all positions by 89bio, consistent with applicable law. Candidates must already hold work authorization, as visa sponsorship is not available for this role. 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 based on disability. 89bio is committed to the full inclusion of all qualified individuals. As part of this commitment, 89bio will ensure that persons with disabilities are provided reasonable accommodations for the hiring process, and/or to perform essential job functions where the requested accommodation does not impose an undue hardship.
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