Regulatory Affairs - Clinical Trials Manager (m/f/x)

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Date: 19-Jun-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 Affairs - Clinical Trials Manager (m/f/x)

Purpose of the function:

 

To serve as a Regulatory Manager for assigned projects and products in the area of Clinical Trials. Represent Regulatory Affairs internally working on a collaborative basis both within Europe and globally to become a fully recognized member of clinical study teams and with other relevant stakeholders, providing EU regulatory strategic support to the Global Clinical Study Teams. Represent Regulatory Affairs on clinical trial related matters working with authorities, affiliates, partners and CROs.

 

Roles and responsibilities:

  • Act as a regulatory contact person for European clinical trial matters within Daiichi Sankyo RA

  • Support with advice and provide clear information to clinical study teams on administrative and process related aspects of clinical trial submissions in the EU and UK

  • Act as a coordinator of responses to agency questions (RFI) within the study team for studies under CTR

  • Review and interpret regulatory guidelines on a regular basis, especially the Clinical Trial Regulation and provide advice and guidance to peers and EU RA study representatives

  • Advise the regulatory strategists and EU product leads on response to RFIs processes

  • Participate or lead assigned non-project tasks and process improvements such as eTMF, SOPs, and anything related to the CTR

  • Become an expert in Clinical Trial Information System (CTIS) and support and guide study teams and other users

  • Keep current with review and interpret Daiichi Sankyo procedures, Daiichi Sankyo internal and external tools and systems and key regulatory regulations, directives, guidelines and initiatives, communicate important changes and trends with the relevant stakeholders

 

Qualification and Requirements:

  • Degree (Bachelor, Master, State Examination, Diploma) in Pharmacy, Medicine, or Life or Natural Sciences; PhD preferred

  • Working experience in Pharmaceutical Industry, at Clinical Research Organizations or at an EU Regulatory Authority with 2- 5 years of experience in Regulatory Affairs with an emphasis on clinical trials

  • Experience in paediatric development and paediatric clinical trials is a plus

  • Experience in managing clinical trials in other regions is a plus

  • Experience of working in global environment

  • Proven ability to plan, coordinate and lead activities simultaneously on multiple projects

  • Excellent personal and intercultural skills paired with the ability to work cross functionally in a multinational organization

  • Ability to develop and maintain good relationships, gain the trust of others, challenge views and present and argue cases in a professional and respectful manner

  • Solution and detail-oriented; well organized and self-motivated

  • Excellent written and oral communication skills in English, second EU language preferred

 

 

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.