Özge Öztop Donelan

⮚ Leading a team of 6 employees

⮚ Analysing regional regulatory requirements and defining the registration strategy to ensure timely and smooth registration processes via international regulatory bodies

⮚ Working in the Business Development Unit on the expansion strategy of the company in new markets: Analysing the impact of regulatory requirements on the business case, contributing to market landscape studies, competitor benchmarking analysis and taking an active role in market entry decisions and market access strategies

⮚ Communicating with regulatory authorities responding to their technical and

administrative questions /requests

⮚ Building relationship with partners from international markets and ensuring a good

communication throughout the projects

⮚ Cooperating with operational departments to ensure compliance with regulations.

⮚ Maintaining current knowledge of regulations applicable to the company

⮚ Contributing to optimization of relevant company processes to ensure lean management principles are applied in day to day business

⮚ Contributing to development projects to ensure that the product development in compliance with international regulatory requirements

⮚ Participation in regulatory processes to gain and maintain European and non-European marketing authorizations for human medicinal products (application, renewal, variations)

⮚ Planning and managing projects for customers to provide the required services in a

structured manner

⮚ Coordinating international projects via communication with international hubs of customers and ensuring optimal and transparent information flow, reporting to head quarter

⮚ General consultancy for customers regarding Regulatory Requirements

⮚ Participation in the preparation, revision and compilation of the informative texts for

healthcare professionals and patients (SmPC, PIL, Labelling)

⮚ Presenting seminars and lectures internally, for customers and for professional audience

⮚ Creating, revising, editing and maintaining regulatory documentation

⮚ Managing out licensing and in licensing projects starting from the R&D phase

⮚ Preparation of labelling texts and product registration files for the international markets

⮚ Coordinating projects for international markets to ensure timely registration of the

products

⮚ Communication with local health authorities and responding to their technical and

administrative questions/requests

⮚ Communication with local representatives and distributors to execute and monitor

international regulatory projects

⮚ Maintaining current knowledge of regulations applicable to the company

⮚ Preparation of new pharmaceutical registration files in Common Technical Document (CTD) format

⮚ Reviewing technical files prepared by R&D and/or Technology Transfer team in terms of the current regulations

⮚ Submitting regulatory files at the health authority, coordinating and monitoring registration process in communication with health authority, relevant units and external stakeholders

⮚ Preparation of labelling texts, non-clinical and clinical summary reports for the pharmaceutical registration dossiers

⮚ Maintaining the registered products

⮚ Preparation of price applications and reimbursement dossiers

⮚ Communicating with regulatory authority, responding to their technical and

administrative questions/requests

⮚ Maintaining current knowledge of regulations applicable to the company

Business Development Specialist

⮚ Coordinating the preparation of business cases for new projects

⮚ Representing the company and relating policies

⮚ Cooperating with marketing and regulatory affairs departments for planning and executing the new business development projects.

⮚ Reporting to management about market demands and evaluating new project ideas

⮚ Ensuring a good communication with the partners worldwide

Internship in Marketing Department

⮚ Preparing training materials for sales force on specific products and/or scientific topics

⮚ Investigating and evaluating feedbacks from the sales force and doctors, assisting product manager in responding to the requests from the field.

⮚ Preparing marketing materials in cooperation with advertising, promotion agencies and creative studios