For our client, Bausch Health - one of the oldest continually operating companies in the US today - we are looking for a Regulatory Affairs Specialist.
- Establishes and maintains good relationship with all involved regulatory institutions in Romania.
- Monitoring, following, reporting and implementing of all local and EU legislation/regulations, Company’s SOPs and Partner companies’ Policies & procedures according to business agreements
- Monitoring national and EU legislation (where applicable) for new information related to the regulation and legislation and inform the appropriate local employees and corporate regulatory functions about the changes
- Preparation and submission to the Authorities of notification dossiers of medical devices and food supplements
- Overall responsibility for regulatory activities in cooperation with corporate functions for company’s products. Keeps up-to date on Company products
- Files preparation & application for: authorization, renewal, variations, transfers, safety alerts, notifications, for all company’s products marketed and/or registered in Romania or new products intended to be marketed in Romania.
- Follows-up all steps for authorization/approval of the above
- Managing of mock-ups/artworks for all company’s marketed medicines, medical devices and food supplements
- Timely information of new submissions, approvals, timelines, deficiency letters, delays, to the relevant staff in Local Affiliate and Corporate Functions and partners’ companies according to business agreements
- Providing information to Global Regulatory Team about submission, timelines, deficiency letters, delays
- Keeping the local and global updated database in line with all registrations and amendments performed through Regulatory Department
- Ensures the application for pricing within the agreed timelines for all new/strategic products that are registered in Romania, and ensure earliest possible price approvals. It is applicable also for annual price corrections. Support commercial in all their promotional activities (eg: in the development and approval of promotional material, presentations etc.); Approve all marketing material to be in line with the approved labeling as per the dossier/ companies policies / local laws; Implementation of Quality Management System and involvement in all relevant quality topics
- Archiving all Regulatory, Pricing, Medical and Quality relevant documents
- University degree, preferably Pharmacy, General Medicine, Bioscience
- Previous experience in the pharmaceutical industry, including Regulatory Affairs - min 2-3 years
- Familiar with current legislation and regulations, European and local, for pharmaceutical products
- Good PC knowledge- MS Office, Internet, Email
- Fluent in both spoken and written English
- Ability to analyze, to prioritize and to plan the activities
- Ability to work independently and in cross functional teams
- Excellent listening and communication abilities
- Strong interpersonal skills
- Open and honest
Grupul Adecco este lider mondial în furnizarea de servicii specializate de resurse umane. Serviciile pe care le oferim vin ca o oglindire a cunoașterii pieței din România și a înțelegerii clare a nevoilor clienților, ca rezultat a 50 de ani în care am acumulat experiență și cunoștințe și în care am implementat tehnici și metode moderne de lucru.