Ensuring compliance of the local product portfolio of medicinal products and food supplements to applicable regulations, guidelines, and internal standards, especially taking in consideration pharmaceutical aspects
Defining the regulatory requirements for local submission of registration dossiers
Initiation of publishing by using electronic databases & repositories and submission to health authorities
Updating and maintaining registration dossiers post registration. This will include the filing of variation submissions
Ensuring the renewal of registration of medicinal products by defining the accurate timelines based on the current requirements
Maintaining and updating regulatory files and records including archiving of all relevant documentation in the respective databases in accordance with legal obligations and internal standards
Keeping abreast of the dynamic regulatory, compliance and statutory requirements in the global, regional and local environment in order to ensure organizational compliance
Ihre Qualifikationen:
PhD or MSc with Life Science background
Regulatory/GPS experience for at least 1-2 years
Fluent in English and Excellent German language skills required
Good communication skills and working in a matrix organization
Understands the impact of the regulatory environment and proposed changes which are likely to impact the business in the medium term
Understanding of regulatory, medical and safety governance.
Ihre Vorteile:
Payment above the general wage scale
A highly motivated team and an open way of communication