Job Description
With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world. In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life. In Oncology, we strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer. Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.
For our headquarter in Munich we are seeking highly qualified candidates to fill the position of
Regulatory Operations Associate (m/f/x)
The Position:
Under supervision, provide regulatory operational support for European submission projects for prospective and authorize products in a timely manner. Ensure regulatory operations compliance and may act as a technical specialist in a particular area. In this role, you will be part of a highly competent team resided in Munich and in Basking Ridge/US.
- 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 Daiichi Sankyo 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)
- 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
- Excellent Benefits
- Work-Life Balance
- Growth and Development
- Health and Wellbeing Support