PASSION FOR INNOVATION. COMPASSION FOR PATIENTS.

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 Daiichi Sankyo Europe GmbH we are seeking highly qualified candidates to fill the position:

PERSONAL SKILLS AND PROFESSIONAL EXPERIENCE:

• Technical assistant (PTA, MTA, CTA, BTA, lab assistant), nurse or equivalent or bachelor degree.
• Several years working experience in pharmaceutical industry, preferred in regulatory affairs, CMC development or in a Clinical Research Organization.
• Team oriented and forward-thinking attitude,
• strong interpersonal and communication skills,
• structured and independent way to working,
• talent for organization,
• computer proficiency (e. g. MS office, document management systems, databases),
• strong written and verbal communication skills in English and German, third language preferred.

PURPOSE OF THE FUNCTION:

Within Daiichi-Sankyo’s Technology Unit, the role of the Regulatory Affairs CMC (Chemistry, Manufacturing and Controls) function is to lead the preparation of dossiers on manufacturing and testing of Daiichi-Sankyo’s development and commercial products across the whole portfolio, and to submit to international health authorities. To ensure high quality standards and latest health authority expectations are met in our dossiers, we are both closely interacting with research laboratory or manufacturing functions within Daiichi Sankyo, and also aiming to maintain a trustful relationship with the health authorities, striving to ensure on-time approval of our drugs and securing patient supply.
Within the EU RACMC Team, the role of the Associate CMC Regulatory Affairs will provide regulatory operational support for development and commercial products of all modalities (i.e. biologics and small molecule portfolio). The role will be embedded in RACMC product teams and is supporting to ensure timely and accurate CMC regulatory product management and compliance of supported projects, meeting overall project objectives.