89Bio
Overview
89bio is a clinical-stage biopharmaceutical company dedicated to the development of best-in-class therapies for patients with liver and cardiometabolic diseases. The company is focused on advancing its lead candidate, pegozafermin, through Phase 3 development for metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG). Pegozafermin is a glycoPEGylated fibroblast growth factor 21 (FGF21) analog with extended half-life. The company is headquartered in San Francisco.
The Role 89bio is seeking an exceptional regulatory strategy leader as the Director of Regulatory Affairs to advance the company\'s mission to deliver innovative therapies for liver and cardiometabolic diseases. The Director will develop and manage all aspects of the assigned clinical regulatory strategy activities in collaboration with internal and external stakeholders. The ideal candidate will have experience with large, complex regulatory submissions (e.g., BLAs/NDAs/MAAs) in a highly competitive regulatory environment. The Director will work closely with and report to the Vice President of Regulatory Affairs.
The Responsibilities
Regulatory Strategy: Collaborate with leadership and cross-functional teams to define clinical regulatory strategies and lead their implementation.
Lead interactions with global Health Authorities (FDA, EMA, MHRA, PMDA, and others) 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.
Collaborate with clinical operations, clinical development, clinical quality assurance, and pharmacovigilance teams to oversee global clinical trials managed by contract research organizations.
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
Bachelors 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 submissions.
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 adapt to new information or changing priorities.
Salary & Level 89bio considers a range of factors when determining salary and level. Actual salary and level may vary. The expected salary range for this position based on the primary location for this position in Northern California is $200,000 – $250,000.
89bio\'s role / level assessment approach involves assessing candidates during the interview process before confirming the level / title designation. The level is assessed on a case-by-case basis. Offer and level are based on factors such as education, experience, qualifications, geographic location, transferable skills, licenses / certifications, and other job-related factors permitted by law.
The Perks
Competitive health insurance coverage
Generous PTO allowance
401k match
Commuter Benefits
Women\'s forum / mentoring
Office based in the heart of San Francisco, near shops and restaurants
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 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.
Notice to Recruiters: 89bio does not accept unsolicited resumes and we ask that employees, hiring managers and executives not be contacted directly. All recruitment is managed through the 89bio Talent Acquisition Team.
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The Role 89bio is seeking an exceptional regulatory strategy leader as the Director of Regulatory Affairs to advance the company\'s mission to deliver innovative therapies for liver and cardiometabolic diseases. The Director will develop and manage all aspects of the assigned clinical regulatory strategy activities in collaboration with internal and external stakeholders. The ideal candidate will have experience with large, complex regulatory submissions (e.g., BLAs/NDAs/MAAs) in a highly competitive regulatory environment. The Director will work closely with and report to the Vice President of Regulatory Affairs.
The Responsibilities
Regulatory Strategy: Collaborate with leadership and cross-functional teams to define clinical regulatory strategies and lead their implementation.
Lead interactions with global Health Authorities (FDA, EMA, MHRA, PMDA, and others) 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.
Collaborate with clinical operations, clinical development, clinical quality assurance, and pharmacovigilance teams to oversee global clinical trials managed by contract research organizations.
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
Bachelors 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 submissions.
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 adapt to new information or changing priorities.
Salary & Level 89bio considers a range of factors when determining salary and level. Actual salary and level may vary. The expected salary range for this position based on the primary location for this position in Northern California is $200,000 – $250,000.
89bio\'s role / level assessment approach involves assessing candidates during the interview process before confirming the level / title designation. The level is assessed on a case-by-case basis. Offer and level are based on factors such as education, experience, qualifications, geographic location, transferable skills, licenses / certifications, and other job-related factors permitted by law.
The Perks
Competitive health insurance coverage
Generous PTO allowance
401k match
Commuter Benefits
Women\'s forum / mentoring
Office based in the heart of San Francisco, near shops and restaurants
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 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.
Notice to Recruiters: 89bio does not accept unsolicited resumes and we ask that employees, hiring managers and executives not be contacted directly. All recruitment is managed through the 89bio Talent Acquisition Team.
#J-18808-Ljbffr