Director CMC Regulatory Affairs (m/f/x)

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Datum: 14.09.2021

Standort: München, Deutschland, 81379

Unternehmen: Daiichi Sankyo Europe

Affiliate: Daiichi Sankyo Europe GmbH

 

Passion for Innovation. Compassion for Patients. ™


Daiichi Sankyo is dedicated to creating new modalities and innovative medicines by leveraging our world-class science and technology for our purpose “to contribute to the enrichment of quality of life around the world.” In addition to our current portfolio of medicines for cancer and cardiovascular disease, Daiichi Sankyo is primarily focused on developing novel therapies for people with cancer as well as other diseases with high unmet medical needs. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation to realize our 2030 Vision to become an “Innovative Global Healthcare Company Contributing to the Sus-tainable Development of Society.” For more information, please visit www.daiichi-sankyo.eu. www.daiichi-sankyo.eu.
 

For our headquarter in Munich we are seeking highly qualified candidates to fill the position:

 

 

Director CMC Regulatory Affairs (m/f/x)

 

 

The position:

 

The Director RACMC 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 interactions in scientific advices, CMOs). The function will lead the preparation of regulatory CMC documents during development and life cycle management as IMPDs and MAAs in a manner that is scientifically sound, commercially viable and in accordance with regulatory CMC standards. The function 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 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:

 

  • Lead regulatory teams to conduct preparation of M2 and M3 CTD documents for EU 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 
  • Review CMC documents, develop regulatory strategies, provide risk assessments
  • Lead the preparation and execution of Health Authority meetings
  • Interpret, develop strategy and lead response preparation on Health Authorities information requests
  • 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
  • Influence the EU regulatory landscape

 

Personal skills and professional experience:

 

  • Master degree in Life Science or Pharmacy, PhD preferred; Master Degree in Regulatory Affairs is a plus 
  • 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 in Europe; experience in the development of 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 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

 

 

 

What we offer:


We offer you exciting projects for which you are independently responsible and an interesting and varied job in a motivated team. In addition, you can expect performance-based remuneration for interns, good contractual conditions and flexible working hours.


Please apply online at our Career Portal. We are looking forward to hearing from you.