As a Submission Publisher you are responsible for preparing and publishing regulatory submissions, ensuring quality, compliance, and timely delivery. You also support regulatory filings and maintain a regulatory database.
- Perform submission publishing activities for different regions using applicable dossier formats.
- Complete required activities within established timelines, ensuring high quality and adherence to regulatory guidelines, applicable standards, styles, guidelines, and processes.
- Utilize current electronic document management and publishing tools to prepare submission-ready regulatory components and assemble, publish, and dispatch dossiers in accordance with regulatory requirements for both paper and electronic submissions.
- Perform quality control checks on electronic and paper submissions to ensure compliance with company and agency requirements.
- Maintain effective communication and interactions with all publishing contributors and responsible regulatory affairs professionals to ensure the timely delivery of dossier components, taking into consideration special requirements and needs.
- Possess knowledge and experience in product registration procedures, covering IND, NDAs, CTAs, BLA, IMPDs, MAAs for regulated markets such as the EU, Australia, and NZI.
- Support regulatory submissions publishing for EDMF, COS/CEP related to drug substances filing.
- Support regulatory submissions publishing for MRP, DCP, CP, and national filings for the EU.
- Review and maintain a regulatory database that comprises existing and new regulations related to submission requirements for the region.
- Degree in Life Science (Pharmacist’s degree is preferred)
- Minimum 6 months experience in EU submissions
- Business 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.