Regulatory Affairs Expert

Regulatory Affairs Expert

Teva

Dupnitsa, Bulgaria

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