Wayne Blevins Email & Phone Number

New York, New York, United States

New York, New York, United States

• Lead Regulatory capability across all clients at Publicis North America employing an adaptive approach from minimal regulatory involvement to full submission, timeline development, and strategy support• Establish best practices and gather detailed knowledge of constantly evolving client submission requirements and platforms• Onboarded, trained, and supervised all new Regulatory department members• Invited by largest client in Publicis Health to be key stakeholder in Bridge initiative to bring 18 disparate systems globally into one enterprise platform for all commercial and medical material review and digital asset management, representing Publicis Groupe throughout two-year initiative from discovery phase through full enterprise wide deployment• Partnered in yearlong integration of two major pharma, including creation of a single harmonized material review process and platform, executing UAT testing of new MRP workflow before rollout• Lead Regulatory efforts for first party data strategy including Personalization, Customer Data Platforms, and Modular Content• Therapeutic Area Experience (Consumer and Professional):Immunology, Oncology, Infectious Diseases, Cardiovascular, Endocrinology, Neurology• Agency CDER and CBER Branch Experience: OPDP, OOPD, APLB

New York, New York, United States

• Recruited by EVP Group Account Director of Publicis NA to create a Regulatory function to support their largest client before her transition to Global Client Lead• Created a consultative two-person approach to maximize quality of submissions whereby regulatory functions as subject matter expert submitting together with Account• Led Regulatory efforts at Publicis NA as the creative AOR for largest brand in client portfolio across multiple indications. Brand exceeded 19 Billion USD in sales for 2018• Initiated material review optimizations partnering with client promotional operations to minimize review time and cost, creating new processes adopted enterprise wide by client• Advised account to help develop most efficient review strategy for all projects through approval for use, serving as a central resource to the agency on submission processes, strategy, and targeted QA • Given Lead Champion roll to represent all Publicis Groupe agencies in client’s Champions program, working closely with Global Client Operations Lead on client process efficiency initiatives and agency material review challenges across the Groupe

New York, New York, United States

• Responsible for managing all aspects of the medical, legal, and regulatory compliance review submission process for pharmaceutical advertising produced by Digitas Health NY.• Key Accounts: SYNTHROID (AbbVie); ABILIFY (BMS/Otsuka); ELIQUIS launch US and EU (BMS/Pfizer); OPDIVO - Subpart E launch, breakthrough therapy and orphan product designation, priority review (BMS); SPRYCEL Subpart H new indication launch (BMS); ERBITUX, XALKORI, TOVIAZ, CHANTIX (Pfizer)• Key Advisory submission types: Preclearance Broadcast TV, Presubmission for accelerated approval, Core Launch Advisory, Launch Advisory Non-Core, Launch Advisory under accelerated review• Built strong relationships with client promotional operations, regulatory and medical reviewers, business technology owners, and platform support capabilities

New York, New York, United States

Summit, New Jersey

• Researched, rationalized and consolidated production monographs through extensive database searches, review of Change Authorizations, Marketing Authorization Application (MAA) pages and international compendia. Ensured production monographs were in compliance with cGMPs and associated Health Regulatory Document (HRD) filings for each country of export• Created, reviewed and updated technical documents (manufacturing procedures, analytical methods, test specifications, raw material monographs) in response to international change requests involving close evaluation of site practices against company quality standards• Collaborated with Global Regulatory Affairs, Global Technical Services, Site Quality Heads, Analytical Science, Stability groups across SP-International sites (Europe, Asia, Latin America) to obtain and clarify information for monograph updates and registration purposes

Summit, New Jersey, United States

New York, New York

• Right First Time group employed Six Sigma DMAIC problem-solving techniques for process optimization and continuous improvement within the Brooklyn pharmaceutical manufacturing plant• Member of various RCATs (Root Cause Analysis Teams) to resolve key manufacturing issues• Managed equipment and process validation, procedural updates, drafting change controls, identifying and implementing Corrective and Preventative Actions (CAPAs) resulting from event and deviation investigations• Member of various committees to identify and implement Cost Improvement Projects. Teams realized total 8.9MM in real plant savings for FY 2006

New York, New York

• Performed HPLC and GC testing for APIs, impurities, degradation products, and residual solvents • Analyzed and reported data, determined whether results complied with USP/EP/JP specs• Performed Analytical Laboratory Investigations (ALIRs) for Out Of Spec/Out Of Trend results

Dallas/Fort Worth Area

• Supported R&D project managers with product development efforts for this Medical Devices group, developing analytical methods and investigating novel ingredients to improve glove utility for surgeons

Bachelor Of Science - Bs, Chemistry

Minor in Mathematics and Physics

Bachelor Of Arts - Ba, Spanish Language And Literature

Minor in French

Preparation For Global Professionals Mba, 3.75

Statistics, Managerial Economics, Fundamentals of Management, and Business Law in preparation to enter program