Experience

MEALIS Turkey

• Türkiye
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Business Development & Regulatory Affairs Director

  • Jan 2023 - Present

• Regulatory Affairs & Business Development Manager

  • Jan 2016 - Jan 2023

  Conduct detailed market analysis, P&L and prepare business plans for the evaluation of new products that are suitable with the company portfolio approachResearch and evaluation of developments and future products, overall Portfolio Evaluation Business and commercial analysis, market assessment, market researchNegotiation of cooperation agreements including the design of the commercial frameworkExpansion and maintenance of an international network with partners from the pharmaceutical industryCommunicates closely with Marketing, Sales, Finance functions for the further feasibility analysis and marketing strategies of new productsBuild up relationship with KOLs, keep close communication for their scientific inputConduct feasibility research studies, prepare forecasts follows closely with the marketing trendsPrepare detailed marketing plans with suggestions of critical success factors Present views to the management team, influence where necessary for investment decisions*Related responsibilities continue as the regulatory affairs manager.

• Regulatory Affairs & Business Development Specialist

  • Jan 2015 - Jan 2016

  Developing new strategic plans to expand the current business and portfolio,Following national and international trends and developments in the sector,Experienced of Due Diligence during the new contractsIdentifying, researching, developing negotiating, planning, timing, tracking new business opportunities with the existing and potential companies,Product Selection, Portfolio - Pipeline Management;Forecasting Conducting all the essential studies for finding new products considering new developments, current portfolio and organizationPreparation of the original, generic, medical device and OTC product applications and ensuring that all required documentation in compliance with MoH regulations is generated, collected, delivered and filed during the registration process. Update and review of SmPC, PIL, packaging and labelling according to the related guidelines. Following up correspondences with Ministry of Health and other ralated authorities and prepare answers on time. Monitor the governance and implementation of new regulations & guidelines concerning registration, pricing and reimbursement. Also ensure that the team is informed of any new and\or developing issues in regards to compliance with global and in-house SOP’s. Monitor all competitive products in the market and keep key personnel informed about all generic and\or competitor products newly entering into the market. Monitor reference prices & prepare price applications. Prepare Market Access plans and the reimbursement application files. Prepare and monitor the registration processes of products; including new submissions & variations and follow-up approval status and provide on-time approval. Contact person for the communications with the Ministry of Health, Social Security Instıtution and all other governmental authorities.



Governmental Agency&Freelance

• Consultant

  • Apr 2013 - Dec 2014



Biem Pharmaceuticals

• Türkiye
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Regulatory Affairs & Business Development Specialist

  • Aug 2010 - Nov 2012

  Following up market trends in Turkey and other markets using different databases like IMS Dataview, Pharmaprojects.Identifying potential products - Rx- original or generic, OTC, medical device that fit into the therapy focus of the company Constantly monitor & analyze the newly marketed products in the pharmaceutical industry: Rx- original or generic, OTC- medical device both of which are registered & marketed in Turkey (including registration approval date, reimbursement approval date, the indications, reimbursement discount rate, etc.) on continual basis.Contacting with potential strategic partners, conducting detailed market analysis including registration and reimbursement process, commercial feasibility, marketing plan, sales forecast, and business case evaluation.Coordination of co-development and technology transfer projects between the partners and the internal departments.Following up and coordinating relations with the licensor companies, government authorities and other departments for timely market launch of new products.Negotiating commercials and contracts with the licensor companies and other internal partners.Establish and maintain communication with new and\or existing business partners, stakeholders, decision makers & KOLs through, most commonly, face-to-face appointments.Ensuring continuity of strong relations with global licensors,government authorities and internal partners.Plan, operate and manage all local operations.Sourcing APIs ,procurement , switch projects and contract manufacturing Project.Representing the company in international partnering meetings like CPhI,GMP inspections. Performance based on new deal creation, new product registration, new product launch.

• Quality Assurance Specialist

  • Nov 2009 - Nov 2012

  Revision of existing SOPs and/or generation of new ones based on the related quality modules. To give basic cGMP and SOP trainings.Performing self and internal inspections, auditing suppliers, attending all audit preparation activities follow up of the actions related to any quality inspection performed by MOH, other sites and health authorities, preparation and updating of action plans; reporting to top management ; following CAPA up; monitoring authority requirements. To review and interpret divisional QA policies ensuring that local procedures are implemented and are compliant to divisional/regulatory requirements

• Regulatory Affairs & Goverment Affairs Specialist

  • Nov 2009 - Nov 2010

  Preparation of the original, generic, medical device and OTC product applications and ensuring that all required documentation in compliance with MoH regulations is generated, collected, delivered and filed during the registration process.Update and review of SmPC, PIL, packaging and labelling according to the related guidelines.Following up correspondences with Ministry of Health and prepare answers on time.Monitor the governance and implementation of new regulations & guidelines concerning registration, pricing and reimbursement. Also ensure that the team is informed of any new and\or developing issues in regards to compliance with global and in-house SOP’s.Monitor all competitive products in the market and keep key personnel informed about all generic and\or competitor products newly entering into the market.Monitor reference prices & prepare price applications.Prepare Market Access plans and the reimbursement application files.Prepare and monitor the registration processes of products; including new submissions & variations and follow-up approval status and provide on-time approval.Contact person for the communications with the Ministry of Health, Social Security Instıtution and all other governmental authorities.



Eczacıbaşı Topluluğu

• Intern

  • Aug 2007 - Sep 2007

  Intern at Quality Assurance Department, Eczacıbaşı Zentiva

• Intern

  • Jun 2007 - Jul 2007

  Intern at Quality Control Department, Özgün Kimya



Trakya Birlik

• Türkiye
• Food and Beverage Manufacturing
• 100 - 200 Employee

• Intern

  • Jan 2007 - Feb 2007

  Intern at QA&QC, Trakya Birlik Intern at QA&QC, Trakya Birlik