Senior Manager (m/f/x) RACMC

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 our headquarter in Munich or in Pfaffenhofen/Ilm we are seeking highly qualified candi-dates to fill the position:

Senior Manager (m/f/x) RACMC 

The position:

The Senior Manager Regulatory Affairs CMC will provide European regulatory CMC guidance and strategy for assigned products and will represent Regulatory Affairs CMC EU in internal and external interactions (e.g. global and local project teams, working teams, authorities communication (Scientific Advice), CMOs). The function will support or lead the preparation of regulatory CMC documents during development and life cycle management in a manner that is scientifically sound, commercially viable and in accordance with regulatory CMC standards. He/She/It may act as a specialist for biological products in the EU regulatory CMC field. The function communicates EU and international regulatory requirements to authoring teams, develop the EU and RoW regulatory strategies and review dossiers and technical documents. The function and the team collaborates companywide within the global RACMC department and technical functions.  The function is proactively influencing the internal, but also external regulatory affairs environment.

Roles and responsibilities:

• Working in regulatory teams to conduct preparation of M2 and M3 CTD documents for EU and RoW LCM, MAAs and IMPDs filings of new drugs, incl. Quality Overall Summary (QOS)
• Represent EU RACMC function in global RACMC and CMC development teams and provide CMC regulatory guidance and strategy
• Support the preparation and execution of Health Authority meetings
• Keep close collaboration with global RACMC colleagues and technical experts, across all regions
• Keep current with, review and interpret regulatory and scientific regulations, directives, guidelines and initiatives, communicate important changes and trends with the relevant stakeholders
• Participate or lead assigned non-project tasks and process improvements
• Ensure maintanance of the regulatory compliance

Personal skills and professional experience:

• Master degree in Life Science or Pharmacy, PhD preferred; Master Degree in Regulatory Affairs is a plus 
• Minimum of 5 years of experience in the pharmaceutical industry
• Minimum of 3 years of experience in global regulatory affairs CMC with emphasis on late stage CMC drug development, Life-Cycle Management, or marketing authorization applications in Europe; experience in biologics preferred 
• 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 organisation
• Experience of working in global environment in interdisciplinary teams 
• Experience of working in or leading interdisciplinary teams
• Solution and detail-oriented; well organised and self-motivated
• Excellent written and oral communication skills in English, German as a second language preferred
• Strong working knowledge of Microsoft Office

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.

For more information: www.daiichi-sankyo.eu