John Whatley

Visionary, initiative-taking, detail-oriented, and accomplished regulatory affairs professional with a solid record of achievements in managing and leading complex regulatory affairs projects resulting in approval of over 20 commercial products (small molecules, vaccines, and biologic's targeting immunology, cardiovascular, and inflammation therapeutic space), including complex device systems for administration. Specialist in the design and implementation of regulatory strategy of class 3 medical device products (i.e., drug-eluting stents for implantation in the cardiovascular system) for submission of Premarket Approvals (PMAs). Adept in defining the target product profile (TPP) for labeling, advertising, and promotional materials by conducting the appropriate risk assessment to ensure claims were justified. Expert in technical writing with expertise in both quality and regulatory documents supporting regulatory submissions and clinical trial documents (i.e., to support Investigational New Device, Exemption, IDE). Flawless business acumen in strategizing and charting the course to ensure successful and timely regulatory approval for regulatory submission plans linked to US and global dossiers (i.e., IND, IDE, BLA, MAA, PMA, PMA 180-Day Supplements, and Annual Reports). Strong foundation in collaboration and influencing teams to complete tasks promptly by utilizing a robust RACI (Responsible, Accountable, Consulted, and Informed) matrix project management tool. Exceptional oversight of regulatory strategy activities (e.g., interactions with notified bodies/health authorities, leading submissions, project management, and processing change controls via electronic data systems such as track-wise and Veeva Vault) for ensuring robust internal and external audit readiness for compliance success. Responsible for leading global regulatory affairs teams utilizing a risk-based approach in the submissions design to ensure that compliance with CMC, clinical, regulatory, quality, and ICH standards/requirements is met. Developed and submitted robust regulatory dossiers for both early and late-stage submissions that capture all necessary elements (such as demonstrating the safety, quality, and effectiveness of the product), assuring approval from global regulators. Outstanding ability to establish and foster relationships built on trust with individuals from multidisciplinary fields (e.g., including the regulatory kick-off team members comprising Quality, Operations, Manufacturing, Stability, Clinical, etc.) and vendors typically involved in the regulatory submission process. Distinctly passionate leader with a focus on leading and building high-performing teams to succeed in highly matrixed organizations, organizational leadership, and change management for global regulatory submissions of combination drug and medical devices, and life-cycle management. Championing the integration of digital tools to increase organizational efficiency and ensuring access, accuracy, and integrity of technical data (i.e., related to the data management plan and data analysis for comparability of analytical methods).