Tamira Wright

Global Regulatory Lead for Combination, Biologics, Drug Products, and Class 3 Devices Responsible for Global Regulatory Strategy Development and Submissions in support of GeoExpansion Activities Regulatory Lead for Global and USA Clinical Protocol & Trials Regulatory Strategy Lead for New Product Development & Cross Functional Team Member Communication & Direct Point of Contact with US-FDA

Serves as the primary regulatory interface with Global Regulatory Authorities, partners, and internal team. Ensures the business needs for the assigned products are met by anticipating, identifying, prioritizing and mitigating regulatory risks while ensuring compliance with all regulatory requirements. Oversees and evaluate country specific registration requirements and develop regulatory strategy for submission and maintenance of product registration outside North America. Prepare and manage Certificates of Pharmaceutical Products. Prepare and review of FDA submissions including NDAs, ANDA’s, Amendments, Supplements, Annual Reports.

Prepare, evaluate, and maintain technical documentation to support regulatory submissions to global health authorities for marketing applications and product registrations. Author and submit CTD dossiers and provide regulatory assessments for product life cycle management. Represent U.S. Regulatory Affairs by assisting in global strategy for maintenance and new license registrations for BLAs.

Responsible for compilation, preparation, and filing of 25+ high quality submissions to domestic regulatory authorities. Submissions including ANDAs, NDAs, supplements, annual reports, DMFs and prepare request for Certificate to Foreign Government/Export. Build and maintain collaborative relationships with FDA by interfacing with reviewers, division heads, and project managers to afford negotiation and/or resolution of complex regulatory issues affecting product review cycle and subsequent approval. Acts as a chief point person for domestic regulatory agency interactions (either written or oral) to accurately describe product process or changes to ascertain product approvals and continual product life cycles.

Managed aspects of employee benefit programs including, FMLA, medical, dental, vision, life and accident disability insurance, flexible spending accounts, employee assistance program, savings and retirement plan, 401(k),for 400+ employees for 2 facilities. Evaluated suitability of candidates based on resume/application, interviews, references, company guidelines, and Equal Employment Opportunity requirements.

Interim Supervisor, Managed five laboratory chemists in Raw Materials QC Laboratory ensuring laboratory operations and documentation were successfully in compliance with cGMP, cGLP, and other regulations. Reviewed Laboratory Batch Records to ensure compliance with SOPs and FDA. Performed checks and reviews of laboratory documentation to ensure error free reporting to timely completion and compliance in OOS, OOT, and IIR investigations and resolution. Also initiated CAPA planning as necessary in order to resolve laboratory problems.