Regulatory Affairs Portfolio Executive
- İstanbul Avrupa Yakası
- Sürekli
- Tam zamanlı
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership – Leveraging our collective expertise to connect people to products and services.Every day, we rise to the challenge to make a difference, and here’s how the Regulatory Affairs Portfolio Executive role will make an impact:The objective of this job is to contribute to the strategic business decisions regarding the licensing of a product in Turkey, within the framework of the the local laws, regulations, guidance and company procedures/policies.To make the applications regarding the licensing processes for new products and regarding the maintaining/improving of the current license status for existing licensed products, in the area of responsibility in accordance with the licensing legislation and company procedures, to follow-up the processes, and to fulfil the approval requirements. Carrying out the works defined as "Key Responsibilities" below, along with all transactions related to compliance with legislation of regulatory.To be responsible for the coordination of preparation/updating of SOPs, reports, presentations, launch tables, budgets and databases and for monitoring the regulations, and to provide support to the department head on strategic issues.Key responsibilities for this role include:To contribute to the strategic business decisions regarding the licensing of a product in Turkey.To carry out all relevant activities in the matters related to prioritization, GMP and registration in accordance with the launch plan for new productsTo carry out the organization of GMP audits, to accompany the audits, and then to ensure the acquisition of the GMP certificate by ensuring that all the associated requirements are met.License and GMP renewal for currently licensed/approved products, Type I and II variations, artwork change applications, SmPC-PIL update applications, sales permission applications, and the meeting of official authorities’ requests; to provide, review and control the dossier and documents, determine and provide the deficiencies, follow-up the internal approvals if available, prepare the application letters and files, make the applications in accordance with local regulation/guidance/announcements, follow-up the process and ensure the approvals.To take actions to prevent the regulatory related stock-out risk for the registered products in the market.To fulfill the registration/approval process requirements for all portfolio.To follow the legislations, to implement the updates in business and transactions, to determine the impacts of the updates for the products and to take the necessary actions, if any to file/to ensure to be filed.To ensure the required information within the scope of legislation and provide technical and operational support in the matters relating to production and quality if needed.Artwork responsibilityThe minimum qualifications for this role are:Bachelor’s degree related field.More than 5 years of industry experienceAdvanced Turkish and English in writing and speaking.Male candidates must have completed their military service.Ability to use Microsoft Office programs effectively.At Viatris, we offer competitive salaries, benefits, and an inclusive environment where you can use your experiences, perspectives, and skills to help make an impact on the lives of others.At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.Viatris is an Equal Opportunity Employer.