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    Regulatory Affairs Manager - St Louis, United States - Harba Solutions Inc.

    Harba Solutions Inc.
    Harba Solutions Inc. St Louis, United States

    3 weeks ago

    Default job background
    Pharmaceutical / Bio-tech
    Description

    Responsibilities:

    • Manage submissions and projects as assigned by Regulatory leadership, ensuring compliance, planning, and execution.
    • Represent regulatory interests on cross-functional teams.
    • Process, interpret, and provide recommendations for complex regulatory strategies.
    • Offer regulatory and technical expertise to cross-functional teams.
    • Critically review documentation for regulatory submissions and suggest necessary revisions.
    • Develop and implement regulatory strategies for CMC aspects of drug development and registration.
    • Lead the preparation and submission of CMC sections of regulatory documents (e.g., INDs, NDAs, BLAs, MAAs) in compliance with global regulations and guidelines.
    • Contribute to defining the Target Product Profile and create compliant drug dossiers for registration.
    • Serve as a liaison for third-party service providers.
    • Maintain a database to track individual and department project deliverables for regulatory submissions and milestones.
    • Develop and implement policies, procedures, practices, and strategies for Regulatory Affairs based on current Health Authority guidelines and regulations.
    • Manage multiple priorities, define issues and obstacles, conduct risk analysis, and execute solutions.
    • Execute objectives in alignment with Regulatory leadership, Marketing, and Global Business Units.
    • Communicate regulatory policy changes to management promptly and provide plans for compliance.
    • Understand and recommend strategies based on current local registration requirements and applicable industry standards.
    • Support the professional development of regulatory staff through mentorship and guidance.
    • Present updates and insights to upper management at required intervals, effectively communicating successes and challenges.
    • Maintain operational compliance with US and international regulatory agencies and guidelines (e.g., FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP).

    Requirements:

    • Bachelor of Science in Chemistry, pharmacy, biology or other life science, plus direct experience managing regulatory activities.
    • Ten or more years of relevant Regulatory Affairs pharmaceutical industry experience.
    • Two years of supervisory experience of direct reports required, matrix management experience preferred.
    • In-depth knowledge of global CMC regulatory requirements, guidelines, and industry practices.
    • Experience in leading new project submission efforts including strategy, compilation, submission, and approval by a health authority.
    • Experience writing Target Product Profiles, non-clinical studies, reviewing Clinical protocols and summary reports.
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