Associate Director Regulatory Affairs

89bio; San Francisco (CA); On-site; USD 185,000 - 225,000; Full time

Job summary

A clinical-stage biopharmaceutical company in San Francisco is seeking an Associate Director of Regulatory Affairs to lead regulatory activities for innovative therapies. The role involves managing submissions to the FDA and collaborating cross-functionally, requiring extensive regulatory experience and strong project management skills.

Benefits

Competitive health insurance coverage

Employee Stock Purchase Plan (ESPP)

Women's forum / mentoring

Office located near shops and restaurants

Engagement opportunities

Qualifications

• 8+ years of pharmaceutical industry experience with regulatory affairs.
• Experience with global regulatory submissions (INDs, NDA/BLAs, MAAs).
• Bachelor's degree required; advanced degree preferred.

Responsibilities

• Lead the preparation of regulatory submissions to the US FDA.
• Collaborate with internal teams to define regulatory strategies.
• Ensure compliance of global GxP activities.

Skills

Regulatory compliance

Project management

Analytical problem-solving

Interpersonal communication

Education

Bachelors degree

Advanced degree in scientific/life sciences

Job description

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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.

THE ROLE

89bio is seeking an exceptional regulatory professional as Regulatory Affairs Associate Director, to join our team and advance our mission to deliver innovative therapies for treatment of liver and cardiometabolic diseases. The Associate Director will be responsible for developing and managing all aspects of the assigned regulatory 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 Associate Director will work closely with and report to the Vice President of Regulatory Affairs.

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 RESPONSIBILITIES

Regulatory Strategy:

• Collaborate with the leadership and cross-functional teams to define regulatory strategies and lead their implementation.
• Lead preparation of briefing documents and meetings with global Health Authorities
• Offer strategic and regulatory compliance input to protocols, reports, and other source documents.

Regulatory Submissions:

• Lead preparation of and ensuring accuracy, completeness, and timeliness of high-quality submissions to US FDA including INDs, IND amendments, annual reports, special designations (orphan, breakthrough, fast track), responses to Health Authority queries.
• Oversee global regulatory submissions by contract research organizations.

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.
• Provide support for inspections by global regulatory agencies and actively engage in formal response to any findings.
• 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
• 8+ years of pharmaceutical industry experience including direct regulatory affairs experience with increasing responsibility
• Extensive experience with global regulatory processes, documents, and requirements (e.g., INDs, clinical trial applications, meeting request procedures and materials)
• 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
• Detail oriented with strong scientific foundation and analytical problem-solving 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 new information or changing priorities
• Ability to travel to SF office 2 times per week or as travel policy requires.

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 $185,000 - $225,000.

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
• Employee Stock Purchase Plan (ESPP)
• 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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research

• Industries

  Biotechnology Research and Pharmaceutical Manufacturing

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