Bilge BIYIK YANARDAĞOĞLU

• Continuous analysis of risks/opportunities to define the best company strategy. Acting a key role at brand teams (local team level). Defines Regulatory strategies considering commercial perspective. Monitoring of the regulatory environment to shape and maximize opportunities for the BMS portfolio. • Coordinating periodic Health Authority (HA) visits to follow-up activities on HA. To perform intense lobbying activities with the external stakeholders to leverage their support. • To establish close relationships with the KOLs and HA. • Contributing/leading/advising/coaching specialists on all regulatory tasks (preparations, submissions, maintenance of NCEs) • Develop registration strategies, prioritize assignments, implement regulatory plan and coordinate multiple projects and activities in accordance with strategic company objectives. • Supervising, coordinating and overseeing the all kinds of submissions according to the local regulations. Ensures scientifically accurate, high quality submissions. • Works in collaboration with government affairs department to influence local policies. • High experience on Oncology/Cardiovascular/Immunology/Rheumatology/HCV portfolio including biotech and orphan drugs. • Manage activities such as audits, agency GMP inspections to Manufacturing sites. These activities include participating to inspections and getting roles to compile CAPA documents as a response to inspection report by a cooperation with sites on time. • Manage the process of pharmacovigilance issues of products as filing routine PSURs and renewals.

• Scheduling and coordination of regulatory affairs strategies within the company. Coordinate all timeline and ongoing strategies of new pipeline products. • Managing timely preparation, submission and appropriate follow-up of new Marketing Authorization applications to Health Authority (My best experience in 2013, achieving the registration approval of new import product in 7 months. At average, 21 months is defined as a registration process timeline for membership companies of AIFD). • Prepare variation, licence transfer, licence renewal dossiers. - Lead the critical transfer projects *transfer of some Lilly company products to BMS; *Diabetes portfolio transfer to Astra Zeneca) • Developed, maintained and improved relations with KOLs especially with the commissions in Turkish Ministry of Health. • Observe the general process of pharmaceutical industries by being in contact with other departments like Marketing, Medical, Manufacturing, Q&A, R&D. • Coordinating, monitoring, reporting and setting timelines for SmPC&PIL variation submissions, safety related submissions, renewals, pharmacovigilance related activities in line with the company requirements and local regulations; ensuring compliance of related global company databases,

• Beside the main Regulatory responsibilities, responsible also for the Pricing activities such as: Setting/implementing product strategy according to pricing legislation and reference Countries. Follow up and organize submissions pricing document for in-line products • Lead the MA transfer activities of Wyeth to Pfizer

• Review all promotional materials in compliance with local regulations of the non-promoted products. • Review Medical Information records in compliance with local and global regulations. • Coordinate internal and external period of AIFD complaints within the other companies. • Management budgets and all official approvals of research projects with Key Opinion Leaders, Pfizer Global Team and MoH. • Coordinating all literature requests between country office and sales representatives.