Mine B. Email & Phone Number

Hamburg, Germany

• Contribute to the project-specific development strategy.• Responsible for the dossier compilation (Module 2- 5) including guidance and review of dossiers from external partners.• Develop solution proposals on topics of pharmaceutical quality in the assigned projects as well as general project-related interface coordination with clinical development management and Licensing.• Coordinate, participate and assist authority guidance requests (Scientific Advice Procedures, Controlled Correspondence etc.)• Communicate, coordinate, and negotiate with national competent authorities, internal and external partners, contract institutions, consultants and clients on quality and regulatory issues.• Assess data and market exclusivity and develop the initial approval strategy for assigned project ideas and projects.• Evaluate regulatory documentation on pharmaceutical quality within the scope of regulatory dossier purchases and in-licensing (Due Diligence)

İstanbul, Türkiye

▪ Manage projects focused on developing biotechnological products and preparation of CMC dossiers, submission, approval, pricing and reimbursement activities▪Serve as the primary point of contact for external stakeholders, addressing inquiries related to regulatory, pricing, reimbursement▪Preparing and supporting product inspections by competent Authorities▪ Interactions and issue resolution with Authorities▪ Supporting Global/Local business teams on day-to-day regulatory inquiries, issues, quality incidents and challenges, including competition or legal challenges

Istanbul, Turkey

▪ Manage and ensure that the Regulatory Plans are in alignment with Launch strategies and the business plans▪ Manage overall workflow across assigned Regulatory Affairs Team to ensure appropriate resource allocation and the highest quality and compliant regulatory activity▪ Build and maintain close communication with health authorities and relevant governmental departments, when necessary, in oral communications to discuss pending or new submissions, regulatory requirements, etc.▪ Preparation, coordination and compilation of administrative and quality parts of regulatory dossiers ▪ Provide timely submission and approval for the agreed pricing and reimbursement plans▪ Support the establishment and maintenance of the Quality Compliance governance,processes and improving overall operating unit capability

İstanbul, Türkiye

Regulatory activities; ▪ Coordinate documentation of source documents and contribute Global Team for CMC preparation (Global, except US)▪ Act as single point of contact and advisor for world wide regulatory intelligence information on the site, ▪ Support the site in generation of effective change control strategies, ▪ Train and develop the site’s personnel on regulatory specific aspects. QA activities; ▪ Contribution to cross-site collaboration within NTO Solids for internal QA audits/ HA inspections (Global, except US),▪ Provide support during GMP site inspections, ▪ Lead internal audits based on site annual plan, ▪ Ensure the Regulatory Compliance of the products manufactured within the site, ▪ Identify Regulatory Compliance gaps and implement the remediation plan, ▪ Provide CPP, GMP, Supplier Documentation for renewal of the products, ▪ Support quality processes such as Product Technical Complaints, Deviations, Change Management, Stability, Validation etc.,▪ Used to manage PQR preparation,▪ Used to manage GMP desktop audits from EU & RoW countries

İstanbul, Türkiye

▪ Coordinate, evaluate, prepare and submit drug registration applications ▪ Build and maintain close communication with health authority and relevant governmental departments

İstanbul, Türkiye

▪ Preparation, maintenance and updating of Global Regulatory CMC dossiers▪ Timely response to inquiries from countries and authorities▪ Technical support of other functions in regulatory issues▪ Review and provide regulatory evaluation of Changed Controls▪ Maintain compliance and regulatory databases and organizing regulatory information and trackin▪ Stay up to date on applicable local and human medicines international regulations

Kırklareli, Türkiye

▪ Manage and report the validation of new processes of commercially manufactured generic products due to Equipment, DS Manufacturer, Manufacturing Process, Batch Size Changes

Kırklareli, Türkiye

▪ Develop and validate analytical methods for development generic products

Master Of Science (M.Sc.), Polymer Science And Technology

Bachelor Of Science (B.Sc.), Chemistry