Teva Pharmaceuticals Regulatory Affairs Associate in Dupnitsa, Bulgaria
Regulatory Affairs Associate
Date: Mar 26, 2020
Location: Dupnitsa, BG, 2600
Company: Teva Pharmaceuticals
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global leader in generic medicines, with innovative treatments in select areas, including CNS, pain and respiratory. We deliver high-quality generic products and medicines in nearly every therapeutic area to address unmet patient needs. We have an established presence in generics, specialty, OTC and API, building on more than a century-old legacy, with a fully integrated R&D function, strong operational base and global infrastructure and scale. We strive to act in a socially and environmentally responsible way. Headquartered in Israel, with production and research facilities around the globe, we employ 45,000 professionals, committed to improving the lives of millions of patients. Learn more at www.tevapharm.com .
Since August 2016 Actavis has been part of Teva. In Bulgaria the combined company is working under the Actavis brand and is the largest employer in the pharmaceutical industry. Actavis - a Teva company - manages two manufacturing plants, sales and marketing organization and a number of global corporate functions.
We are looking for qualified and motivated candidate for the role of Associated Regulatory Affairs , based in Dupnitsa manufacturing site.
The Regulatory Affair Associate has the responsibility of obtaining and maintaining marketing authorizations, by providing regulatory expertise and support about Module 3 (CMC section), for EU and International markets.
• 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 the 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
• University degree, ideally in Pharmacy, Chemistry or in other area, but pertinent with the field
• Preferably at least 2 years of experience in the pharmaceutical industry
• Experience in Drug Regulatory affairs and/or Quality and/or in Analytics will be an asset
• Good communication skills (both written and verbal English) and interpersonal skills
• Organized with good time management skills.
• Pro-active and result oriented
• Able to adapt and respond to internal (e.g. priorities) and external (e.g. regulatory environment) change
• Must have an eye for detail and a methodical approach to work
• Computer literacy. Must be experienced in the use of spread sheet and word-processing programs. Specialized software, like Trackwise and Document Management System, will be an asset
• 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 a an international company
• Included transportation from certain locations
If this sounds like the right opportunity for you, send us your CV in English.
Please kindly note that only shortlisted applicants will be contacted. All personal data is protected by law and will be treated in confidence.
Medical Regulatory Affairs
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