Director Regulatory Affairs CMC (m/f/x)

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Date: 29-Sep-2020

Location: Munich, Germany, 85276

Company: Daiichi Sankyo Europe

Affiliate: Daiichi Sankyo Europe GmbH

 

Passion for Innovation. Compassion for Patients.™

Daiichi Sankyo and its 15.000 employees in more than 20 countries are dedicated to the creation and supply of innovative pharmaceutical products. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology. Our European headquarters are in Munich, Germany and we have affiliates in 13 European countries including Denmark, where Copenhagen acts as the Nordic headquarter. For more information: www.daiichi-sankyo.eu.

 

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

 

 

Director Regulatory Affairs CMC (m/f/x)

 

 

Purpose of the function:

The Director Regulatory Affairs CMC leads and conducts the preparation of European submissions for new drugs, as IMPDs and MAAs, but also supports major post-approval changes. The function communicates EU and international regulatory requirements to authoring teams and develops the regulatory strategies. The functions collaborates companywide within the global RACMC department and subject matter experts, as well as with the colleagues at our technical manufacturing site in Pfaffenhofen an der Ilm. The Director RACMC reviews dossiers and technical documents.

 

Roles and Responsibilities:

  • Lead and 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 regulatory teams for 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 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
  • Represent EU RACMC for projects in managment and steering commitees
  • Participate or lead assigned non-project tasks and process improvements
     

 

Skills and additional Requirements:

  • Master degree in Life Science or Pharmacy, PhD preferred; Master Degree in Regulatory Affairs is a plus 
  • Minimum of 8 years (5 years for Sr. Manager RACMC) of experience in the pharmaceutical industry
  • Minimum of 5 years (3 years for Sr. Manager RACMC) 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 
  • 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 an interesting, diversified and challenging position, good contractual conditions, flexible working models, all the social benefits of a modern company and a professional environment where you will have the opportunity for personal growth.

 

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