CMC Regulatory Affairs, Senior Director

THE COMPANY

89bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases. The company's lead product candidate, pegozafermin (BIO89-100), is a specifically engineered glycoPEGylated analog of FGF21. Pegozafermin is being developed for the treatment of nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). 89bio is headquartered in San Francisco with operations in Herzliya, Israel.

THE ROLE

Reporting to the Vice President of Regulatory Affairs, the Senior Director, CMC Regulatory Affairs will function as the internal regulatory expert and point of contact on regulatory CMC activities and in coordination across the Regulatory function.

THE RESPONSIBILITIES

• Lead the development and implementing regulatory strategies for development assets in accordance with domestic and international regulations and guidance for combination products (Drug and Drug Device combinations).
• Responsible for the preparation and submission of combination product sections for commercial or new products such as pre-filled syringes and auto injectors.
• In depth knowledge of global drug and combination product guidelines regarding IND/CTA, original NDA/MAA, agency background packages, post-approval submissions/variations, 510(K)s, CE marking and responses to health authority questions per established business processes and systems.
• Development, communicate, implement and maintain detailed, global regulatory strategies for submission and approval of complex INDs, NDA/BLAs/MAA, agency background packages, post-approval submissions/variations, and responses to health authority questions according to defined timelines.
• Provide detailed, global regulatory assessments for changes to device and drug-device combination products according to existing global guidelines and policies and determine and communicate the regulatory reporting requirements.
• Support device design control activities and documentation reviews as needed.
• Contribution to and execution of regulatory strategy for drug development in alignment with company goals.
• Excellent technical writing skills and attention to detail
• Ability to read, analyze, and interpret scientific, technical data, and regulatory guidelines and regulations.
• Collaborate with partner groups in the authoring and reviewing process to ensure compliance, scientific excellence, accuracy and completeness of submissions
• Track queries with regulatory agencies, provide written responses to queries, and supply management along with providing status updates.
• Perform research for regulatory strategy development for clinical development projects.
• Collaborate with project teams to ensure standards and protocols are followed.
• Ensure regulatory submissions follow the project timeline.

THE QUALIFICATIONS

• MA Chemistry.
• 10 years of experience in regulatory affairs CMC product development.
• Industry / regulatory experience in pharmaceutical or combination product research, development and/or manufacturing.
• Experience with CMC regulatory (IND, CTA, BLA, MAA).
• Demonstrated sound understanding of related fields (e.g., manufacturing, process development, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving.
• Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly, and conclusions are adequately supported by data.

THE PERKS

• Competitive health insurance coverage
• $150/ monthly non-taxable remote work stipend
• 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

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 on the basis of disability. Proof of COVID vaccination is a condition of employment.

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