Tata Consultancy Services (TCS) is an IT services, consulting, and business solutions provider partnering with the world’s largest businesses in their transformation journeys.
- Perform Submission publishing activities for the different regions with applicable dossier formats.
- Perform the required activities within established timelines that are of high quality with adherence to regulatory guidelines and applicable standards, styles, guidelines, and processes.
- Perform peer review and quality control review of the documents within established timelines with adherence to applicable guidelines and processes, using appropriate checklists.
- Utilize current electronic document management and publishing tools to prepare submission-ready Regulatory components and assemble, publish and dispatch dossiers according to regulatory requirements for paper and electronic submissions;
- QC electronic and paper submissions to ensure compliance with company and agency requirements;
- Provide component-level publishing support to ensure submission components conform to e-submission standards (e.g., templates, scanning, indexing);
- Maintain effective interactions with all publishing contributors and responsible RA professionals, to ensure timely delivery of dossier components taking into consideration special requirements and needs
- Maintain open and timely communication, and Participate in special projects and process improvement initiatives.
- Knowledge and experience with product registration procedures covering IND, NDAs, CTAs, BLA, IMPDs, and MAAs for regulated markets like the EU and Australia-NZ.
- Support regulatory submissions publishing for EDMF, COS/CEP for Drug substance-related filing.
- Support regulatory submissions publishing MRP, DCP, CP, and National filing for the EU.
- Reviews and maintains a regulatory database comprising existing and new regulations pertaining to submission requirements for the region.
- Regular interaction with internal stakeholders and external stakeholders like Local Affiliates
- Escalates unresolved issues appropriately as per the agreed escalation process.
- Ensures that the Quality and TAT targets defined are met
- 6-12months of experience in submissions for EU regions
- Experiences in submission publishing tools like Insight Publisher and other leading electronic publishing tools
- Good knowledge of MS Office tools (Word, Excel, and PowerPoint)
- Business fluency in French and English
- TCS has been delivering services from Hungary since 2001, making us a perfect choice if you’re looking for stability.
- We provide a wide range of benefits, including a market leading comprehensive private health care package.
- We offer extensive self-development opportunities: our colleagues have a multitude of training possibilities for personal and professional growth.
- At TCS Hungary there are both vertical and horizontal career options for those who like to challenge themselves and try out different areas and positions.
- You will be part of a global and diverse working environment with relaxation areas, terraces, and a friendly atmosphere.
- You can seize the day with us at our company events, hobby clubs, and sporting initiatives.
- An attractive compensation package.
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