- Bewerber Login
- Registrieren
- Bewerber Login
- Bewerber Registrierung
-
Stellenangebote
- Mein Lebenslauf
-
Arbeitgeber entdecken
-
Arbeitgeber entdecken
-
-
Beruf und Karriere
-
Beruf und Karriere
-
- Magazin
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 EU regional headquarters (position can also be based in an EU affiliate) we are seeking highly qualified candidates to fill the position:
Position could be filled Europewide, Munich preferred
Position is a part time role, 20h/week, preferred whole days or afternoon
Unlimited position
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. Supporting the clinical study teams and other relevant stakeholders, providing EU regulatory strategic project management to the Global Clinical Study Teams. Represent Regulatory Affairs on clinical trial related matters working with authorities, affiliates, partners and CROs.
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 Europe (EU, UK, CH)
Act as a coordinator of responses to agency questions (RFI) within the study team for studies in Europe (EU, UK, CH)
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
Education
University Degree (Bachelor, Master, State Examination, Diploma) in Pharmacy, Medicine, or Life or Natural Sciences or University Degree in Medical Science PhD
Work Experience
2 to 5 years: 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
Project Management skills would be 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 project
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
