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 site in Pfaffenhofen/Ilm or Munich we are seeking highly qualified candidates to fill the position:
Strategist / Director (m/f/x) Regulatory Affairs CMC
Purpose of the function:
The Global Strategy RACMC Department is part of the Global RACMC department, which belongs to the Technology Unit. The mission of the Global Strategy Department is to develop and implement one concise global regulatory affairs (CMC) strategy for all late-stage and commercial products including the 5 main ADC programs but also early-stage development programs.
The function consists of Global Leader RACMC and Project Manager (RACMC) leading the Global RACMC project teams, consisting of member from all 4 regions, i.e. AMERICAS, EU, JAPAC and CN. The Global Strategy members are responsible to lead and/or support the teams, form one G-RACMC voice, develop and successfully implement RA CMC strategies and communicate with key internal and external stakeholders as GPT, CMC Project Lead, QA Lead, G-RA Lead Function and partner companies.
Roles and Responsibilities:
1. Lead team of Project Manager as team-leader (as non-line-management function), by leading, coaching and mentoring the 5 ADC Project Manager
2. Facilitate ADC Global Leader and early development stage Global Leader in setting up harmonized Regulatory Strategies, Ways of Working, Working Guidances, Tools and Processes
3. Lead and/or support major RACMC project and non-project activities as M3 Templates Working Team, Global RACMC Strategy Documentation, Digital Collaboration and Knowledge Management Initiatives and Budget and HC Planning
4. Facilitate Global RACMC Project Committee Meeting as highest G-RACMC project governance body, chaired by Head Global Strategy RACMC
5. Conduct Sr. Reviews of major ADC submissions for Global Strategy RACMC department, such as IND/IMPDs and NDA/BLA/MAAs
6. Support Head Global Strategy and Global Leader with interaction with key stakeholders outside and inside of Technology Unit
7. Collaborate with global Quality Assurance functions on securing and overseeing the compliance with GxP requirements and Regulatory Affairs functions on aligning RA and RACMC portfolio strategy, systems and processes
8. Collaborate with G-RACMC colleagues from all global regions (as AMERICAS, CN, EU and JAPAC)
9. Support development and implementation of innovative digital knowledge management tools and systems
10. Support development and/or streamlining existing Regulatory Affairs CMC processes and tools
11. Participate in global industry organization collaborations
12. Keep current with, review and interpret regulatory and scientific regulations, directives, guidelines and initiatives, communicate important changes and trends with the relevant stakeholders
Professional experience & education:
13. Master Degree in Life Science, PhD preferred
14. Minimum of 8 years of experience in the pharmaceutical industry
15. Minimum of 5 years of experience in global regulatory affairs CMC with emphasis on late-stage CMC drug development and marketing authorization applications; experience in the development of biologics preferred
16. Scientific know-how pharmaceutical development, manufacturing, and control of drug substances and drug products of biological products
17. In depth knowledge in global Regulatory Affairs CMC (RACMC) of biological products
18. Experience in working in global pharma industry
19. Experience in working in global interdisciplinary teams
Personal skills:
20. Proven ability to plan, coordinate and lead activities simultaneously on multiple projects
21. Strong IT/Digital skills
22. Strong project management skills
23. High level of analytical thinking
24. Excellent personal and intercultural skills paired with the ability to work cross functionally in a multinational organization
25. Solution and detail-oriented; well organized and self-motivated
26. Excellent written and oral communication skills in English, German as a second language preferred
27. Open-minded, showing accountability
28. Ideally proven leadership skills in an intercultural team environment
29. 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.