1.Active participation in the development of assigned projects:
• Provide regulatory advice for developing and producing the required product for the targeted countries within the defined timelines and quality standards.
• API: assess from a regulatory perspective the regulatory and technical documentation of the potential and selected source(s) (Technical Data Packages, Drug Master Files and Certificates of Suitability).
• API and excipients: provide regulatory support to the R&D team and/or QC for creating or amending and justifying the development/production and registration specifications in line with current regulatory requirements for the targeted countries;
2.Achieve and maintain marketing authorizations in target countries, the main tasks being:
• Collect, evaluate and criticize data for inclusion in marketing authorization dossiers;
• 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
• Keep the dossier master files (Module 3 and corresponding QOS) fully up to date during registration procedures and as a consequence of a variation or of a site transfer.
3.Contribute to regulatory life-cycle management by:
• Actively participate in the change control system and variation process
• Perform the task for regulatory change control evaluation: inform the US/CA/JP/LATAM and other regions, as applicable;
• Contribute to Technical Data Packages and participating actively in transfer teams as required;
• API: assess from a regulatory perspective the regulatory and technical drug substance documentation in case of second API source or update of Drug Master Files/CEP taking into account the quality of the material and of the documents already approved.
• Provide regulatory support to the Stability unit for designing the stability program for supporting the post-approval change.
• Prepare the variation and post-approval change packages and other necessary documents as required by the variation process;
• Respond to queries (from regulatory authorities, Teva internal departments/affiliates or clients) concerning changes;
• Evaluate and advise on the regulatory implications of proposed changes.
4. Annual Report Notification (USA/Canada):
• Collection and delivery of requested documentation to USRA for Annual Report completion according to the reporting date defined.
5. Provide regulatory expertise and support to Teva’s internal departments/affiliates and Medis’ customers on technical and regulatory issues concerning registration or post-approval change documents;
• Ensure that all documents and records pertaining to the CMC Department are archived properly. Keep departmental database or other tracking system up to date;