Regulatory Affairs Specialist - Минск - вакансия 961384


Дата: 25.11.2021

Город: Минск

Сфера деятельности: Продажи и оптовая торговля

Текст вакансии:

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries. Established Pharmaceutical Division . We’ve never taken good health for granted. Whether it’s an ordinary headache or a more serious illness, we want people to get better, fast, so they can go back to doing the things they love. That’s why we take pride in offering affordable, high-quality, trusted medicines that have been helping millions of people around the world lead healthier lives. But we don’t stop there. We continuously improve medicines based on local market insights to make them better, easier to administer and faster to act. Every day, more than 14 million people around the world use our medicines to help them live healthy lives. Office in Minsk, Abbott Laboratories GmbH Representative Office in Minsk1st Zagorodnyj lane, 20 (office 1503) REGISTRATION ACTIVITIES According to regulatory plan for new registration/renewal/all kind of variations and according to the decisions taken in the strategy, request and follow-up the receipt of all required registration dossiers from Regional Office / Global RA on time. Review and evaluation of the documents/dossier originated from Global RA; initiation and performing of pre-submission activities (selection of documents for translation, coordinate with cross-functional departments)/obtain all the certificates and other documents necessary for application/submission on time. Prepare the Dossier per local/EAEU requirements with appropriate translations for submission (administrative part, chemical and pharmaceutical; pre-clinical and clinical parts) for the New Registration/Renewals/Variations of the Products according to the corporate requirements. Control and maintenance of registration process timelines (PR creation, obtaining of the Primary/Specialized Agreements and management of its payment, timely LHA answers providing, close communication with LHA (and appropriate departments of it) Order/receive samples and reference standards for the registration purposes on time for submission. Control and follow up expenditures connected with registration activities in Belarus. Ensure product registration is completed on time to support NPI timelines. Fulfils proper and timely implementation/update of the company global, regional and local processes, systems, initiatives. LABELING & PACKAGING ACTIVITIES PACKAGE INSERT Ensure package insert is routed to Medical/PV Department for approval before LHA submission. Follow up MoH approval and place all approved local labelling according to corporate SOP at corporate LABELING Follow up approval process of MoH and give approval for implementation of new artworks on time according to plan. Ensure regulatory compliance in preparation, review and approval of labelling/artworks development for marketed products in Belarus. NEW PRODUCT LAUNCHES Actively participate in new product task forces and support Sales & Marketing Divisions for new products launches in Belarus. Ensure new product labelling is finalized for Sales Permission for targeted launch date. OTHER RESPONSIBILITIES RELATED TO ACTIVITY OF MEDICAL AND REGULATORY DEPARTMENT UPON REQUEST Keep abreast of new and/or evolving local regulations, guidelines and policies especially as it pertains to the registration and other activities related to marketed products. Monitor regulatory reforms and industry trends. Inform on time Global RA about all changes in local legislation. Manage the regulatory component of all trademarks where applicable. Prepare and provide Regional CIS office/Global RA with all necessary plans/reports within requested timelines. Fulfil ASR/QA back-up responsibilities where necessary and after completion of all required training. Requirements: Higher education (Pharmaceutical/Medical/ Natural science degree), English (written/verbal - Upper Intermediate), Russian fluent, Work experience from 2 years in Regulatory Affairs, Skills: excellent time-management skills, target-oriented, attention to details, critical and analytical thinking, ability to meet strict deadlines, self-disciplined, proactive; collaborative, diplomatic, hardworking; Ability to work with big amount of information. If you are interested in this opportunity, please do not hesitate to reach out and apply with your CV.

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