Eylem Demir Sentürk Email & Phone Number

Basel, Bs, Ch

Basel, Lichstrasse 35, Ch

𝑨𝒅𝒗𝒂𝒏𝒄𝒊𝒏𝒈 𝑾𝒐𝒎𝒆n🔹Equipping women with the tools, strategies, mindset, visibility & network to thrive and excel in their professional journeys🔹Increasing the number of women & female leaders within the Swiss Industry🔹Training women so that they are aware of their market value, negotiate their worth & are rewarded equitably for their skills, expertise, and dedication🔹Increasing the representation of women in board and corporate leadership roles𝑪𝒐𝒏𝒏𝒆𝒄𝒕𝒊𝒏𝒈 𝑾𝒐𝒓𝒌 & 𝑻𝒂𝒍𝒆𝒏𝒕𝒔🔹With our Sponsoring Women Program we connect female talents/leaders/students with Leaders who grant them access to hidden job market🔹This program is an innovative & creative way to identify, attract & recruit female talents & leaders where organizations become fully independent from recruitment agencies𝑰𝒏𝒄𝒍𝒖𝒔𝒊𝒗𝒆 𝑶𝒓𝒈𝒂𝒏𝒊𝒔𝒂𝒕𝒊𝒐𝒏𝒂𝒍 𝑪𝒖𝒍𝒕𝒖𝒓𝒆𝒔🔹Facilitating Women Empowerment workshops, trainings & Events to overcome biases towards women & to foster an inclusive corporate culture

Creative Team Events for CompaniesCreative workshops for Adults (unbox your creativity)

Leverkusen, North Rhine-Westphalia, De

➢Managed MAA activities with EMA, FDA, Swissmedic & TGA ➢Developed an in-house CTA group and processes ➢Managed various Phase I-IV CTA activities in the EU, Switzerland & ROW➢Proof read various commercial & clinical labels (English, German & Turkish)➢Developed CTA management strategies under consideration of CTRegulation➢Provided trainings on CTRegulation, Directive & VHP➢Prepared of Food Supplements dossier for the Turkish Market

Basel, Baselstadt, Ch

*Above and Beyond Award for excellent contribution to the new CTA Regulation Project *Above and Beyond Award for ensuring business continuity➢Provided strategic input, support to global Regulatory Affairs and conducted risk management assessment➢Maintained Quality Management System system to ensure RA compliance➢Acted as advisor for MAH transfer and CTA Sponsorship transfer (Alcon & GSK)➢Acted as advisor for updating Novartis GOPs and SOPs according to the EU CTRegulation➢Prepared RA for internal Audits and HA inspections ➢Reviewed and approved all RA processes and training materials➢Designed and delivered trainings in conflict management, behavioral change and motivation increase to 600 Basel employees

St. Gallen, Switzerland, Ch

➢Together with the line Manager, Managed all aspects of MAA activities with FDA, EMA, Swissmedic, TGA & HAS:• Management of HA questions and responses• Coordination of the safety reporting to HAs• ATC application • Management of EU Pediatric Investigation Plan & Pediatric IMPD• Review of commercial label text based on CCDS

Summit, New Jersey, Us

➢Managed a CTA group (7 CTA Experts and 1 Publisher)➢Oversaw 35 Phase I -III Studies within EEA in oncology, inflammation & immunology➢Managed 19 Global Phase II/III Studies in parallel ➢Provided strategic consultancy on CTAs to the global study teams & CROs➢Managed the CTA Budget from Regulatory perspective

Summit, New Jersey, Us

➢Trained & Mentored 5 CTA Experts, 1 Publisher, 1 Commercial labeling Expert & 1 Clinical trial labeling Expert➢Managed 15 phase I to III Studies in oncology within EEA➢Submitted over 100 CTAs & 300 amendments within EEA including Switzerland➢Reviewed 15 study protocols, 4 IBs & 4 IMPDs, various ICFs & Insurance certificates➢Prepared & maintained Regulatory budget for CTA activities➢Interacted with EU & Swiss HAs regarding CTA submissions and related queries➢Participated in GCP audits➢Delivered presentations to global study teams on CT Directive & CTA guidance➢Defined CTA submission strategy & delivered presentations to global study teams

Summit, New Jersey, Us

Joined the Company as 4th EU Regulatory Member, 1st EU CTA Expert in order to build and manage a CTA group➢Successfully built a Clinical Trial Group within Celgene➢Established strong working network with the US Headquarter, EU Affiliates,internal departments & CROs➢Developed & implemented a CTA tracking system that tracks all CTA activities➢Built a clinical trial label text database in English & EU languages according to Annex 13➢Set up an in-house paper archiving system & ensured electronic archiving of CTA documentations systematically➢Authored SOPs on management of CTAs, ASR, PSUR and RMP ➢Brought outsourced studied in-house & managed them➢Reviewed, approved ASRs & PSURs and ensured regular distribution to HAs

Basel, Ch

➢Managed CTA submissions to EU Regulatory Agencies➢Verified study drug release documentation and gave green light for study drug release➢Ensured proper archiving of CTA documentation

Basel, Ch

➢Supported Project Managers in compilation of MAA dossiers for submissions in Turkey & Asian pacific countries➢Supported Project Managers with Type I & Type II variations➢Coordinated the translation of EU commercial labels➢Supported Project Managers with preparation for Scientific Advice Meeting & Briefing Book➢Requested Certificate of Medicinal Products (CPP) from EMEA and Swissmedic

Certificate, The Science Of Learning

Certificate, Family Engagement In Education

Master Of Science (Msc), Applied Psychology

Certificate, Drug Registration Dossier

Regulatory Affairs Certificate, Regulatory Affairs

Gmp For Imps

Certificate In Management Of Clinical Trials & Basic Statistics, Management Of Clinical Trials & Statistics For Clinical Trials

Education record