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Dossier scientific writer (Regulatory Affairs)
Kantoor gebaseerd in HU - Budapest
Job domein
: MinőségirányításContract
: MunkakörBeschikbaarheid
: 21/10/2020Job description
We are looking for aDossier scientific writer (Regulatory Affairs)
for our Biological Registration Dossier Team
Major responsibilities:
Write dossiers or part of dossiers (quality, safety and efficacy documentation for marketing authorization applications)
Write answers to technical questions received from authorities during registration procedures
Be member of project teams as the regulatory correspondent
Support in defining R&D project content so they are regulatory compliant
Participate in the problem-solving process in case of conflict between regulatory requirements and scientific/technical issues
Maintain product life cycle management for selected products (participation in change control process, write variations)
Requirements:
University degree as Veterinarian, Biologist, Bio or Chemical-engineer, Microbiologist or in related areas
Relevant experience in area of vaccines regulatory is an advantage
Proficiency in English, both writing and speaking
Professional written and oral communication and organizational skills
Ability to analyse issues objectively, strategically and globally
Ability to work as part of multidisciplinary teams and on several projects simultaneously
Ability to anticipate, respond quickly, recommend
Stable computer skills
Advantage:
Professional experience in regulatory affairs related activities
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