Job description:

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.

Requirements:

• 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.