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    Executive Director, Clinical Regulatory Affairs

    Arrowhead Pharmaceuticals, Inc
    7+ years
    USD 200,000 - 250,000
    Pasadena
    10 Aug. 2, 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, 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

    Position Title: Executive Director, Clinical Regulatory Affairs

    Company: Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR)

    About Arrowhead Pharmaceuticals: Arrowhead Pharmaceuticals is a clinical-stage biopharmaceutical company dedicated to developing innovative treatments for intractable diseases by silencing the genes responsible for these conditions. Leveraging advanced RNA chemistries and efficient delivery methods, our therapies induce RNA interference to achieve deep and durable gene knockdown.

    Position Overview: The Executive Director of Clinical Regulatory Affairs will report directly to the Vice President of Regulatory Affairs. This role leads the Clinical Regulatory sub-team and oversees Clinical Regulatory submissions across Arrowhead’s entire pipeline.

    Responsibilities:

    • Regulatory Expertise: Provide clinical regulatory guidance and leadership to ensure credible and trustworthy interactions with health authorities, supporting the submission of scientifically robust data in compliance with quality standards.
    • Agency Interaction: Engage proactively and independently with FDA and international regulatory agencies, communicating company positions effectively.
    • Vendor Management: Supervise and collaborate with external service vendors, contractors, and consultants as needed.
    • Submission Management: Obtain and generate information and documents for regulatory submissions, develop planning timelines, and coordinate with team contributors for effective regulatory document preparation.
    • Documentation Review: Offer regulatory subject matter expertise during the review of documentation, protocols, and reports, and prepare additional written materials as necessary.
    • Compliance: Review and interpret regulatory rules related to Company products and clinical studies, communicate these through company policies, and recommend compliance strategies for existing and new products.
    • Infrastructure Development: Lead the development of regulatory functional infrastructure, including electronic documentation management systems, electronic publishing systems, and documentation templates. Oversee Regulatory Affairs Standard Operating Procedures (SOPs).
    • Team Support: Serve as a backup to the Vice President of Regulatory Affairs on core teams and assist in submission risk assessments.
    • Budget Management: Handle project budgets as assigned.

    Requirements:

    • Education: Bachelor’s degree in a science-related field (advanced degree preferred).
    • Experience: 10+ years of relevant experience in a regulated drug environment.
    • Regulatory Knowledge: Extensive understanding of regulations and guidelines governing all phases of drug development (pre-IND through post-approval) and global clinical regulatory requirements, especially for key countries outside the US such as the EU and Australia.
    • Track Record: Proven success in regulatory filings, including several INDs and at least one registrational filing (e.g., NDA/BLA/MAA).
    • Leadership: Experience leading teams through major regulatory agency interactions (e.g., FDA pre-NDA meetings, EOP2 meetings, advisory committee meetings, EU oral explanations/scientific advice).
    • Technical Skills: Highly proficient in MS Word, Adobe Acrobat, and PowerPoint.

    Preferred:

    • Electronic Submissions: Experience with electronic submission systems (e.g., Veeva RIM System or equivalent).

    Salary: $280,000 — $320,000 USD

    Arrowhead Pharmaceuticals offers competitive salaries and an excellent benefits package. Applicants must have authorization to work in the US.

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