89bio
Overview
Join to apply for the
Director of Regulatory Affairs
role at
89bio . 89bio is a clinical-stage biopharmaceutical company focused on liver and cardiometabolic diseases, advancing its lead candidate pegozafermin through Phase 3 development for MASH and SHTG. The company is headquartered in San Francisco. SPECIAL ADVISORY The FTC has an advisory out on the domain 89biocareers.com. If contacted by any group using a similar domain, please report any scams.
The Role
89bio is seeking an exceptional regulatory strategy leader as Regulatory Affairs Director to develop and manage all aspects of the assigned clinical regulatory strategy 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 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, etc.) by developing strategy and briefing documents, and leading agency meetings.
Regulatory Submissions: Oversee the preparation and ensure accuracy, completeness, and timeliness of submissions to US FDA and global health authorities including BLAs, MAAs, INDs, amendments, annual reports, designations (orphan, breakthrough, PRIME, fast track), responses to queries, and pediatric study plans.
Cross-functional Collaboration: Represent Regulatory in project and study teams and support development teams in applying regulations and guidance documents; collaborate with clinical operations, clinical development, clinical QA, and pharmacovigilance to oversee global 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 appropriate to the company’s development stage; ensure regulatory compliance of global GxP activities; perform other duties as assigned.
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 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 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 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 assessment is considered 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
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; 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. Persons with disabilities will be provided reasonable accommodations for the hiring process and essential job functions where the requested accommodation does not impose an undue hardship.
Notice to Recruiters: 89bio does not accept unsolicited resumes. All recruitment is managed through the 89bio Talent Acquisition Team.
Seniority level
Director
Employment type
Full-time
Job function
Strategy/Planning and Quality Assurance Industries: Biotechnology, Research and Pharmaceutical Manufacturing
Referrals may increase your chances of interviewing at 89bio.
#J-18808-Ljbffr
Join to apply for the
Director of Regulatory Affairs
role at
89bio . 89bio is a clinical-stage biopharmaceutical company focused on liver and cardiometabolic diseases, advancing its lead candidate pegozafermin through Phase 3 development for MASH and SHTG. The company is headquartered in San Francisco. SPECIAL ADVISORY The FTC has an advisory out on the domain 89biocareers.com. If contacted by any group using a similar domain, please report any scams.
The Role
89bio is seeking an exceptional regulatory strategy leader as Regulatory Affairs Director to develop and manage all aspects of the assigned clinical regulatory strategy 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 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, etc.) by developing strategy and briefing documents, and leading agency meetings.
Regulatory Submissions: Oversee the preparation and ensure accuracy, completeness, and timeliness of submissions to US FDA and global health authorities including BLAs, MAAs, INDs, amendments, annual reports, designations (orphan, breakthrough, PRIME, fast track), responses to queries, and pediatric study plans.
Cross-functional Collaboration: Represent Regulatory in project and study teams and support development teams in applying regulations and guidance documents; collaborate with clinical operations, clinical development, clinical QA, and pharmacovigilance to oversee global 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 appropriate to the company’s development stage; ensure regulatory compliance of global GxP activities; perform other duties as assigned.
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 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 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 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 assessment is considered 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
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; 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. Persons with disabilities will be provided reasonable accommodations for the hiring process and essential job functions where the requested accommodation does not impose an undue hardship.
Notice to Recruiters: 89bio does not accept unsolicited resumes. All recruitment is managed through the 89bio Talent Acquisition Team.
Seniority level
Director
Employment type
Full-time
Job function
Strategy/Planning and Quality Assurance Industries: Biotechnology, Research and Pharmaceutical Manufacturing
Referrals may increase your chances of interviewing at 89bio.
#J-18808-Ljbffr