Regulatory Affairs Director (San Francisco)

THE COMPANY

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). Pegozafermin is a specifically engineered, potentially best-in-class fibroblast growth factor 21 (FGF21) analog with unique glycoPEGylated technology that optimizes biological activity through an extended half-life. The company is headquartered in San Francisco.

SPECIAL ADVISORY

The FTC has an advisory out on the domain 89biocareers.com if you are contacted by any group using a similar, but not our exact domain 89bio.com, please Report any Scams

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 ideal candidate will have experience with large, complex regulatory submissions, such as 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 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.

• Collaborate with clinical operations, clinical development, clinical quality assurance, pharmacovigilance team 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

• 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. These considerations mean 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 assessment is considered on a case-by-case basis. Offer and level is 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
• 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

CONDITIONS OF EMPLOYMENT

• Background investigations are required for all positions by 89bio, consistent with applicable law.

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.

Notice to Recruiters : To protect the interest of all parties, 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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