Regulatory affairs specialist Jobs in Petershausen

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 :

Product Owner Quality (m / f / x) – Antibody Drug Conjugates

The Position :

Roles and responsibilities :

• Manage global quality oversight for the assigned product You are responsible as global quality lead for the assigned product You work together with different functions from global QA, CMC, Regulatory Affairs and Supply Chain in a matrix organization to define the strategical approach to solve challenges in the day-to-day business You review and evaluate documents like APQRs, PPQ reports or CTDs You trend the development of the assigned product from a quality-related perspective and keep the senior management and the team informed about respective developments You identify quality risks related to the assigned product and in case necessary you escalate issues to senior level management You keep close contact to the teams managing the manufacturers as well as the MAH related functions You support the organization during submissions in GMP-related matters and if required during Authority Inspections related to the assigned product
• Act as global information distributor You monitor quality-related information from different markets and clinical studies to ensure a consistent global understanding of the assigned product You support global teams and SMEs to identify quality-related risks at an early stage and support on every level to find suitable mitigation measures You collect and share quality related information in all directions to our global stakeholders within the global QA environment as well as in department overarching teams
• Participate in the further development of the corporate QM-System You act as a SME to help improving the global Daiichi-Sankyo QMS and global SOP landscape Share knowledge and expertise within the DS network to improve QA and CMO management at DS

In this role you will work globally in close cooperation with other departments like Supply Chain, CMC, Regulatory Affairs and others to ensure consistent supply to markets with products which meet our high-quality standards at any time. This requires an extensive understanding of the pharmaceutical industry and multi-cultural work environments.

Personal Skills and professional experience :

Why work with us?

Working at Daiichi Sankyo is more than just a job – it is your chance to make a difference and change patients’ lives for the better. We can only achieve this ambitious goal together. That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.