Strategist/Director Regulatory Affairs CMC

Daiichi Sankyo Europe

Munich, Germany

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

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