Regulatory Operations Specialist (m/f/x)

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Date: 06-Aug-2022

Location: Munich, Germany, 81379

Company: Daiichi Sankyo Europe

 

Passion for Innovation. Compassion for Patients.

 


Daiichi Sankyo and its 16,000 employees in more than 20 countries are dedicated to the creation and supply of innovative pharmaceutical products. In Europe, we focus on two areas: In the cardiovascular space, our strong portfolio of medicines reflects our long-standing commitment and shows that we care for every heartbeat; in oncology our goal is to become a global pharma innovator until 2025 by providing novel therapies to patients across the world. Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries. For more information: www.daiichi-sankyo.eu.

 

For our headquarter in Munich we are seeking highly qualified candidates to fill the position:

 

Regulatory Operations Specialist (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 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.


Roles and responsibilities:

  • Support submission processes by leading submission team meetings, create and maintain document/submission timelines, provide guidance and advice
  • Check documents of accuracy and consistency regarding authority and DS standards
  • Preparation of the assigned eCTD submissions in collaboration with the EU Regulatory Affairs and Regulatory Operation counterparts in the US
  • Ensuring 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
  • 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
  • 1-2 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 and German

 

 

 

What we offer


Working at Daiichi Sankyo

At Daiichi Sankyo in Europe, we offer a workplace where your voice is heard. Everything we do, we do with a high level of commitment and a clear focus on patients’ needs. We know that our bold ambition to change patients’ lives for the better can only be achieved through the power of collaboration and the exploration of new approaches. Thus, we encourage our colleagues across Europe to be courageous, to bring their ideas to the table and to embrace opportunities to grow. When you join our European family, you will be a part of a dynamic company where everyone, no matter their role, rolls up their sleeves and gets things done.