Job Description

Roles and Responsibilities:

• Preparation of the assigned eCTD submissions in collaboration with the EU Regulatory Affairs and Regulatory Operation counterparts in the US

• Responsible for the control of Client document standards are adhered

• Ensuring on-time delivery of high quality, compliant and valid eCTD submissions for the different countries

• Manage the dispatch of the submissions via diverse electronic submission channels (e.g. CESP, EMA Gateway)

• Knowledge of the Health Authority guidelines concerning the electronic submissions and ensuring their proper application

• Participating in special projects (e.g. developing processes within the team’s area of responsibility)

Personal Skills and Professional Experience:

• Bachelor’s degree in natural science or PTA education

• 2-3 years of experience in the regulatory environment

• Hands-on experience with the eCTD compilation and publishing

• Proven ability to work with a document management system and an electronic publishing tool

• Used to work towards deadlines and able to prioritize

• Collaborative and service-oriented mindset

• Strong working knowledge of Microsoft Office

• Written and verbal communication skills in English, German is a plus