Strategist / Director (m/f/x) Regulatory Affairs CMC

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:

• Lead team of Project Manager as team-leader (as non-line-management function), by leading, coaching and mentoring the 5 ADC Project Manager
• Facilitate ADC Global Leader and early development stage Global Leader in setting up harmonized Regulatory Strategies, Ways of Working, Working Guidances, Tools and Processes
• 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
• Facilitate Global RACMC Project Committee Meeting as highest G-RACMC project governance body, chaired by Head Global Strategy RACMC
• Conduct Sr. Reviews of major ADC submissions for Global Strategy RACMC department, such as IND/IMPDs and NDA/BLA/MAAs
• Support Head Global Strategy and Global Leader with interaction with key stakeholders outside and inside of Technology Unit
• 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
• Collaborate with G-RACMC colleagues from all global regions (as AMERICAS, CN, EU and JAPAC)
• Support development and implementation of innovative digital knowledge management tools and systems
• Support development and/or streamlining existing Regulatory Affairs CMC processes and tools
• Participate in global industry organization collaborations
• 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:

• Master Degree in Life Science, PhD preferred
• Minimum of 8 years of experience in the pharmaceutical industry
• 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
• Scientific know-how pharmaceutical development, manufacturing, and control of drug substances and drug products of biological products
• In depth knowledge in global Regulatory Affairs CMC (RACMC) of biological products
• Experience in working in global pharma industry
• Experience in working in global interdisciplinary teams

Personal skills:

• Proven ability to plan, coordinate and lead activities simultaneously on multiple projects
• Strong IT/Digital skills
• Strong project management skills
• High level of analytical thinking
• Excellent personal and intercultural skills paired with the ability to work cross functionally in a multinational organization
• Solution and detail-oriented; well organized and self-motivated
• Excellent written and oral communication skills in English, German as a second language preferred
• Open-minded, showing accountability
• Ideally proven leadership skills in an intercultural team environment
• 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