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WÖRWAG Pharma located in Böblingen near Stuttgart is a mid-sized, international pharmaceutical company. As a family-owned company we develop and distribute biofactors and generics. We are represented in more than 35 countries with about 1000 employees.


Become a part of our team because we are looking for you as a

 

Regulatory Affairs Specialist CMC (m/f/d) 

Tasks and responsibilities:

 

  • Plan CMC regulatory activities for assigned biofactor products
  • Forecast expected costs of all CMC regulatory activities and adhere to budget
  • Write CMC documents and ensure their compliance with the regulatory requirements
  • Ensure that CMC documents keep fit for regulatory purposes
  • CMC support of regulatory projects in a European and global context
  • CMC support to the deficiency letter answering process concerning biofactor products

 

Requirements:

 

  • Completed studies in pharmacy or a related natural science
  • At least 2 years of professional experience in Regulatory Affairs preferentially at a CMC group
  • Good knowledge of pharmaceutical analytics, pharmaceutical technology and pharmaceutical biology and pharmacology
  • Good knowledge of regulatory guidelines and regulations with focus on the CMC requirements of the EU and the ICH
  • Accurate, analytical, independent, integrative and responsible working practices
  • Cross-departmental and process-oriented work
  • Good knowledge in process and project management
  • Assertiveness, resilience, reliability, capability of conflict management, value-oriented thinking and acting
  • Very good command of English, good German language skills of advantage

 

What we offer:

 

  • We offer you a challenging and varied scope of tasks in a dynamic team of a successful, mid-sized  pharmaceutical company
  • We offer you exciting projects in an international work environment, with the opportunity to quickly take responsibility and to share your experiences and knowledge
  • In addition to a performance-based salary you receive a comprehensive offer of additional benefits, for example including an occupational pension provision, workplace health promotions, a job ticket as well as diverse training offers

 

We are looking forwar to receiving your application!