Actively participate in meetings related to registration procedures or when CMC expertise is needed. Tightly collaborate with Submission RA functions for assigned products.
Collect and critically evaluate data for inclusion in marketing authorization dossiers.
Compile module 3 and corresponding module 2.3 Quality Overall Summary (QoS) for presentation to regulatory authorities or clients, taking all necessary measures to ensure that dossiers meet relevant, current requirements and trends.
Critically evaluate the content of module 2.3 and module 3 in terms of completeness and relevance for supporting a new registration.
Respond to queries (from regulatory authorities or clients) concerning dossiers. Manage the process to respond to the CMC questions by involving all stakeholders both within and outside the company (e.g. suppliers) and follow up agreed actions in order to respond as rapidly and completely as possible. Contribute to regulatory lifecycle management by:
Actively participate in the change control system and variation process. Propose classification of the variations and adhere to the workflow established between Site RA and Submission RA functions.
Evaluate changes and prepare the variation packages and other necessary documents as required by the variation process.
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. Ensure that the documentation is appropriate for the required purpose and targeted countries. Liaise with the API supplier(s) as needed.
Drug product: provide regulatory support to site units for QC and the Stability unit for creating or amending the products’ specifications or any other strategy or decision needed for supporting regulatory submissions.
Contribute to renewal applications or annual reports.
Respond to queries (from regulatory authorities, internal departments/affiliates or clients) concerning changes.
Provide regulatory expertise and support, the main tasks being:
Keep up to date with regulatory and other developments in the pharmaceutical industry, including relevant legislation and guidelines (EU, US and RoW) and pharmacopoeias.
Provide information, support, and advice to TEVA’s internal departments/affiliates and clients on technical and regulatory topics concerning registration or post-approval change documents.
Representing Site Regulatory Affairs in small project teams.
Ensure that all documents and records pertaining to the Site RA Department are archived properly. Keep departmental database or other tracking systems up to date.
Abide by the ICH guidelines and other relevant regulatory provisions, GMP requirements, occupational and environmental safety guidelines and internal SOPs, and ensure that all required training has been conducted and documented as appropriate.
Create and keep updated the SOPs specific to the Site RA Department and ensure that the related training is performed and documented.