Job Description
With over 120 years of experience and approximately 19,000 employees in more than 30 countries/regions, 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 are driving innovation in solid tumours and blood cancers, founded on breakthrough science from our own labs in Japan. We aspire to create better tomorrows for people living with cancer and their loved ones.
Our European headquarters are in Munich, Germany, and we have affiliates in 15 European countries and Canada.
We are seeking highly qualified candidates to fill the position of:
Regulatory Operations Specialist (m/f/x)
The Position:
Under supervision, provide regulatory operational support for European submission projects for prospective and authorized 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.
- Support submission processes by participating in submission team meetings, create and maintain document/submission timelines, provide guidance and advice
- Check documents for accuracy and consistency regarding authority and DS standards
- Prepare assigned eCTD submissions in collaboration with the EU Regulatory Affairs and Regulatory Operations counterparts in the US
- Ensure on-time delivery of high quality, compliant, and valid eCTD submissions for the different countries including 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
- Participate 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 project management and eCTD compilation/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