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About the role
- Analytical CMC Writer supporting regulatory and analytical documentation in the pharmaceutical sector at Richter. Involves collaboration across teams and regulatory compliance activities.
Responsibilities
- All around regulatory support of Richter manufactured active substances (API) and drug products (DP), primarily authoring the chemical and analytical documentation of Module 3 in english
- Collecting GMP 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.
- Finding ways for smart AI applications to enhance regulatory efficiency
- Initiation, evaluation 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
Requirements
- 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
Benefits
- 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 employment plan
- Great variety of professional and non-professional trainings and courses
- Care and attention in a dynamic team
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
No Education Requirement
Location requirements
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