Regulatory Affairs Expert
Dupnitsa, Bulgaria, 2600
Who we are
As a global leader in generic medicines with a strong innovative portfolio, we are all in for better health.
Teva Pharmaceuticals has been developing and producing medicines for more than 120 years. Along with our established presence in generics, we have significant research and operations supporting our growing portfolio of innovative medicines and biopharmaceutical products.
Today, our portfolio of around 3,600 products is among the largest of any pharmaceutical company in the world. Nearly 200 million people in 60 countries benefit from one of Teva's quality medicines every day. We invest in research and development of innovative medicines, generic drugs and biosimilars, carrying on the legacy of more than a century of finding new ways to help patients improve their lives. This defines our values as a company and characterizes how we do business and approach medicine.
This defines how we do business and motivates thousands of Teva employees all over the world, every single day.
Learn more at www.tevapharm.com.
In Bulgaria Teva (known as Actavis until 2020) is the largest employer in the pharmaceutical industry with near 1700 employees in the two manufacturing plants (Dupnitsa and Troyan), sales and marketing organization and in a number of global corporate functions based in our country. We believe that each and every one of us should have access to quality medicines that help manage illness, fight infection or simply support overall health.
Learn more at www.teva.bg.
Currently we are looking for а qualified and motivated candidate for the role of experienced Regulatory Affairs Expert, part of the Registration Documentation Department based in Dupnitsa manufacturing site.
The opportunity
The Regulatory Affair Expert has the responsibility of obtaining and maintaining marketing authorizations, by providing regulatory expertise and support Module 3 (CMC section), for EU and International markets.
How you’ll spend your day
• Collect and evaluate data for inclusion in marketing authorization dossiers (Module 3)
• Compile dossiers (Module 3 and corresponding QOS) for presentation to regulatory authorities or clients, taking all necessary measures to ensure that dossiers meet relevant, current requirements while not being overly restrictive
• Respond to queries (from regulatory authorities or clients) concerning dossiers submission or changes. Manage the process to respond to the CMC questions by involving all stakeholders both within and outside the company and following up agreed actions in order to respond as rapidly and completely as possible
• Prepare variation and post-approval change packages and other necessary documents as required by the regulatory post-approval processes
• Maintain the dossier (Module 3 and corresponding QOS) fully up to date during registration procedures and as a consequence of a variation or of a site transfer
• Ensure that the documentation of the Active Substance Master Files is appropriate for the required purpose and targeted countries
• Actively interact and provide information, support and advice to Teva’s internal departments/affiliates and clients on technical and regulatory issues concerning registration or post-approval change documents
• Review for regulatory compliance the analytical validation, stability or other protocols with regulatory or compliance impact
Your experience and qualifications
• University degree in Pharmacy, Chemistry, Biology, Biochemistry or another relevant area
• Background in Drug Regulatory affairs/ Quality/ Analytics spheres
• Additional experience in the pharmaceutical industry would be preferred
• Good communication skills in English (both written and verbal)
• Excellent organizational and time management skills
• Team player, pro-active and result oriented attitude
• Ability to adapt and respond to internal and external change (e.g. priorities/regulatory environment)
• Eye for details and methodical style of working
• Computer literacy (ability to work with spreadsheet and word-processing programs) is a must
• Experience in using specialized software (e.g. Trackwise/ Document Management System) would be an asset
Enjoy a more rewarding choice
• Dynamic and challenging work environment in a highly motivated team of professionals
• Competitive remuneration bound with performance
• Job specific training
• Additional benefits as per the company policy
• Opportunity for development in an international company
• Included transportation from Sofia, Pernik, Kyustendil, Blagoevgrad
Make a difference with Teva Pharmaceuticals
All personal data is protected by law and will be treated in confidence. Only short-listed candidates will be contacted.
Already Working @TEVA?
If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site
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