Company Info
The responsibilities for this position include but are not limited at:
Main Tasks and Key Responsibilities
• 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
Qualifications
• University degree, ideally in Pharmacy, Chemistry or in other area, but pertinent with the field
• Experience in Drug Regulatory affairs and/or Research and/ or Quality 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
If you have the skills and experience that we are looking for and would like to work in a fast paced and dynamic environment, then we’d love to hear from you!
Ideal profile:
Function
Regulatory AffairsSub Function
Medical Regulatory AffairsAlready Working @TEVA?
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Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.
