LEADERSHIP.Strong leader who gains commitment and engagement from direct reports and creates strong morale and spirit in her team. Possesses a high degree of credibility by gaining trust and confidence of others. A respected role model and comfortable empowering others. Strong strategic and operational presence with the proven ability to develop integrated plans and to drive performance to achieve objectives. Forward thinker with a creative mindset who creates competitive and breakthrough strategies. KEY HIGHLIGHTS:✔ Global Regulatory Affairs: As SrVP Regulatory Affairs - functionally managed >600 FTE globally. Regulatory accountability for product portfolio from early development to post-approval activities. Led organization through 8 global NME submissions across different therapeutic areas. Broad experience in working with FDA and European Agencies. ✔ QUALITY MANAGEMENT: VP Quality Medicine - Development and post-approval Quality Management System for Medicine. Implemented lean SOP system reducing documents > 60%. Inspection oversight for multiple sponsor inspections allowing for timely regulatory approval. ✔ ORGANIZATIONAL DEVELOPMENT: Newly established Global Labeling and Global RA Operations as function in Global Regulatory Affairs leading to stronger product labels and increased operational efficiency. Revamped Regulatory and Quality information management establishing central oversight and compliance. ✔ REGULATORY POLICY: Influenced regulatory policy through interaction with regulatory stakeholders via Efpia and PhRMA. ✔ TALENT MANAGEMENT: Developed high performing teams motivated to succeed, with a passion for mentoring and coaching team leaders.FUNCTIONAL & TECHNICAL EXPERTISE:Global Regulatory Affairs and Global Quality Management in Development and Post approval, Regulatory Strategy, Marketing Authorization Applications in the US and Europe, INDs, Labeling, CMC for small molecules and biologics, Therapeutic Areas: Metabolic, Immunology, Respiratory, CNS, Oncology, Cardiovascular. Quality Management, Auditing, SOPs, Inspections, Issue and Risk Management. Contact: richtemo@gmail.com, or 203-770 6405 with any Questions or Opportunities