The role compiles, reviews, and publishes submissions in eCTD format:
- Use the electronic publishing software according to the system User Guide and internal procedures.
- Work closely with local and corporate Regulatory Affairs to support the preparation of eCTD submissions.
- Compile and publish submissions in eCTD format for NP products according to EU requirements on eCTD format and internal procedures.
- Review submissions in eCTD format for DCP/MRP products according to EU requirements on eCTD format and internal procedures.
- Import to the electronic publishing software eCTD applications that have been published in different systems.
- Maintain an archive of approvals received from regulatory agencies.
- Prepare and maintain cumulative approved dossiers in eCTD format.
- Support the electronic submissions using EU submission portals: CESP, EMA WebClient.
- Follow up on the assigned tasks and deadlines.
- Monitor the status of the eCTD applications.
- Stay up to date with the EU requirements on eCTD format.
- Report electronic publishing software issues to the Help Desk of the software provider.
- Maintain regulatory databases and trackers updated.
- Perform regular corporate trainings requested.
- University/ college degree in Chemistry, Biology, Pharmacy, Medicine, Life Science.
- General knowledge of Regulatory Affairs processes.
- Fluent written and spoken English.
- Ability to prioritize own workloads to meet deadlines.
- Result and detail-oriented approach to work delivery and output.
- Enthusiastic, proactive, self-driven, and willing to take over new responsibilities.
- Team player and also able to perform alone.
- Strong communication, interpersonal, and organizational skills.
- Problem solving skills.
- Excellent computer skills including MS Office applications.