Regulatory Affairs Contractor

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 

Reporting to the Vice President, Regulatory Affairs, the Regulatory Affairs Contractor -Sr. Management level will be expected to work 30-40 hours a week and be responsible for fulfilling the following: 

THE RESPONSIBILITIES  

• Regulatory oversight and execution for 89bio clinical studies 

• Represent 89bio regulatory affairs on internal clinical study teams and external clinical research organization and vendor interactions 

• Oversee global regulatory submission preparation, review, and tracking for global clinical trial applications 

• Maintain knowledge of current global regulations and regulatory guidance 

• 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 ; advanced degree in scientific/life-sciences or related field preferred  

• 3+ years of pharmaceutical industry experience in regulatory affairs experience  

• Extensive experience with global clinical trial applications 

• Strong organizational, project, and time management skills  

• Comprehensive knowledge and understanding of global regulations and guidelines for clinical trials   

• Excellent interpersonal skills enabling productive cross-functional collaboration with internal and external stakeholders 

• Detail oriented with strong scientific foundation and analytical problem-solving skills 

SALARY & LEVEL 

89bio considers a range of factors when determining salary and level. These considerations mean actual salary and level may vary. The expected hourly rate for this position based on the primary location for this position in Northern California is $95 - $120/hr.

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. 

CONDITIONS OF EMPLOYMENT 

• Background investigations are 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.