Job Description

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



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