Analytical CMC Writer

Tasks

• All around regulatory support of Richter manufactured active substances (API) and drug products (DP), primarily authoring the chemical and analytical documenation of Module 3 in english
• Collecting data, reports and documentation from various teams and departments of Richter Gedeon in order to adequately compile Module 3 documentation
• Participation in the operation of various regulatory teams
• Coordination of responses to Health Authority defficiency letters along with quality assurance dept., as well as authoring responses in english
• Handling administrative and documentation types of activities for compiling submission dossiers in Veeva
• Authoring GMP documents for laboratory and regulatory purposes, translation of short documents and technical descriptions
• Initiation and coordination of quality change controls (TrackWise sytem) in cooperation with the quality assurance dept.
• Operating as a cross functional link bridging various internal departments (domestic and foreign) across the company for providing documentational input for the submissions

Required skills and knowledge

• Relevant educational qualification, such as an M.Sc. degree in pharmacy, chemical engineering, bioengineering etc.
• Minimum 1 year of pharmaceutical industry experience, preferably, in regulatory and/or GMP QC laboratory field
• Professional working proficiency in English (primarily in writing,in reading too)
• Computer and software skills (Microsoft office).Veeva knowledge is an advantage.
• Flexibility, motivation to contribute, good communication skills, and precision in data handling
  
  

Other information

• The position is fixed-term ( appr. 2 years)

We offer

• Competitive compensation package (cafeteria, insurances, pension fund, stock option etc.)
• Comprehensive healthcare program, free access to Richter’s medical center, and health insurance plan
• Motivating challenges to promote your development in a multinational environment
• Long term employement plan
• Great variety of professional and non-professional trainings and courses
• Care and attention in a dynamic team