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)

➢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

*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

➢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

➢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

➢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

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

➢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

➢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