Director of Regulatory Affairs

Job Description

Job Description

Salary : 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 the Director of Regulatory Affairs, 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.

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.

Represent the Regulatory department in project and study teams and support development teams in interpreting and applying regulations and guidance documents.

Maintain knowledge of current global regulations and regulatory guidance.

THE QUALIFICATIONS

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.

89bios 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

CONDITIONS OF EMPLOYMENT

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.