William J. Foster
Regulatory Operations Specialist @MRM
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WORK HISTORY
Regulatory Operations Specialist @MRM
Perform advanced back-referencing for OPDP submissions, annotating promotional claims directly on source documents (clinical study reports, PI, and primary literature) to maintain traceability and facilitate FDA reviewer verification.Manage Veeva PromoMats annotation workflows, ensuring alignment between claims and underlying data while supporting high-quality, compliant promotional materials for launch and post-approval activities.Collaborate cross-functionally with medical, legal, regulatory, and commercial teams to align submission priorities and resolve workflow issues efficiently.
EDUCATION
University of Westminster
Legal Practice Course (Supreme Court of England and Wales), Bar exam
The College of Law
CPE (GDL), Law
University of Natal, Howard College School of Law
LLB (Law Post Graduate Degree), Law
Hilton College
Matriculation with University Exemption
University of KwaZulu-Natal
Bachelor of Arts, English, History and South African Law
ABOUT WILLIAM J. FOSTER
Senior Promotional Review and Regulatory Operations Specialist with expertise in managing end-to-end PRC/MLR workflows and Veeva PromoMats submissions within pharmaceutical and life sciences environments. Skilled in facilitating live MLR meetings, agenda planning, and scribing, ensuring high-quality, compliant promotional materials aligned with FDA OPDP guidelines and product labeling.Extensive medical editing and annotation experience.Adept at cross-functional collaboration to drive process improvements, streamline workflows, and support product launches and label updates within tight timelines.
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