Dossier scientific writer (Regulatory Affairs)

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Office based in HU - Budapest

Job domain : Minőségirányítás
Contract : Munkakör
Starting from : : 21/10/2020

Job description

We are looking for a

Dossier 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
Knowledge of regulatory environment, EU and international requirements
Experience in negotiation with authorities

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