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    Director/Sr. Director, Regulatory Affairs

    Calcilytix & Bridgebio Pharma
    8+ years
    $230,000 - $290,000 USD
    San Francisco
    10 Nov. 27, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Director/Sr. Director, Regulatory Affairs
    Location: San Francisco, CA/Hybrid
    Salary: $230,000 - $290,000 USD
    Company: Calcilytix & BridgeBio Pharma

    About Calcilytix & BridgeBio Pharma

    Calcilytix Therapeutics, an affiliate of BridgeBio Pharma, is developing Encaleret (CLTX-305) for the treatment of Autosomal Dominant Hypocalcemia Type 1 (ADH1), a genetic cause of hypoparathyroidism. Currently in Phase 3 clinical studies, Encaleret has received Orphan Drug and Fast Track Designations from the US FDA. BridgeBio Pharma, established in 2015, bridges advancements in genetic science to deliver transformative medicines for genetic diseases and cancers.

    Responsibilities:

    • Regulatory Documentation: Plan, coordinate, review, and assemble regulatory submissions (e.g., INDs, NDAs, CTAs, MAAs, etc.) for FDA, EMA, and global agencies.
    • Regulatory Strategy & Planning: Provide regulatory direction to project teams, develop regulatory strategies, and communicate timelines to ensure timely submission.
    • Cross-functional Collaboration: Work with internal teams to ensure regulatory compliance in key documents such as protocols, ICFs, IBs, and CSRs.
    • Vendor Management: Coordinate with vendors to finalize submissions and ensure compliance with regulations.
    • Regulatory Knowledge: Maintain up-to-date knowledge of global regulations (e.g., ICH, GCP, GMP) and guidelines.

    Qualifications:

    • Bachelor’s degree (life sciences preferred) with 8+ years of experience in regulatory affairs in biotechnology/pharmaceuticals.
    • Experience with eCTD submissions (INDs, NDAs, MAAs, etc.).
    • Regulatory expertise in FDA/EMA/global guidelines and drug/biologics development.
    • Excellent communication and time management skills.
    • Ability to work independently, prioritize tasks, and manage multiple projects under tight deadlines.

    What We Offer:

    • Patient Days to hear directly from patients and improve efforts.
    • A culture of transparency, excellence, and a focus on patient-first values.
    • Competitive compensation, including base pay, performance bonus, equity, and health benefits.
    • Flexible PTO and rapid career advancement.
    • Opportunities to work on multiple BridgeBio programs and across various therapeutic areas.

    For more details, visit Calcilytix and BridgeBio Pharma.

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