Regulatory Affairs Associate I

3 days ago

Lake County, United States Katalyst HealthCares & Life Sciences Full time

Job Description:The Regulatory Affairs Associate will be responsible for managing, authoring, and compiling Chemistry, Manufacturing, and Control (CMC) sections of regulatory submissions for marketed product variations, including Class III implantable medical devices. This position involves coordinating cross-functional activities to ensure timely and accurate preparation of submission documents while maintaining compliance with FDA and international regulatory requirements. Responsibilities: Manage, compile, and author CMC sections (Module ) of marketed product variations in accordance with Common Technical Document (CTD) standards. Partner with Regulatory Affairs CMC Project Leads and cross-functional teams (R&D, Manufacturing, Quality) to develop timelines and collect supporting documentation. Author and submit PMA supplements, including -Day Notices, Real-Time Reviews, -Day Supplements, and Annual Reports. Review and approve engineering and validation study protocols, reports, and manufacturing change documentation for Class III implantable medical devices. Ensure submission content meets file-ability and acceptance requirements for global regulatory authorities. Manage multiple projects simultaneously, ensuring completeness, accuracy, and timely delivery of CMC dossiers and responses. Independently facilitate and lead project meetings to align team activities and communicate progress updates. Maintain awareness of FDA guidance documents, CFR regulations, and international regulatory requirements for CMC dossiers. Ensure regulatory documentation adheres to company standards and best practices for electronic document management and regulatory business systems. Adjust priorities and strategies as needed to meet project scope changes and evolving business objectives. Work collaboratively across diverse global teams and maintain effective communication with all stakeholders. Demonstrate strong attention to detail, accuracy, and commitment to high-quality submission preparation. Requirements: Bachelor's degree in chemical, Biological Sciences, or a related discipline. – years of pharmaceutical industry experience, including cross-functional project management. Experience with electronic document management systems and regulatory submission tools. Strong oral and written communication skills, with the ability to collaborate effectively across global teams. Highly organized, detail-oriented, and capable of managing multiple projects independently. Familiarity with US and international regulatory requirements for CMC dossiers Preferred: Master's degree in a scientific or regulatory discipline. – years of experience in regulatory affairs, R&D, or manufacturing (including CTD Module preparation). Recent experience with Class III implantable medical devices and authoring/submission of PMA supplements. Knowledge of FDA PMA guidance documents, CFR regulations, and regulatory pathways for device modifications. Proven track record in successful regulatory submissions and approvals.

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