Regulatory Affairs Manager (m/f/d)
Your responsibilities
- 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
Your profile
- 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.
Your benefits
- Payment above the general wage scale
- A highly motivated team and an open way of communication
- 30 days leave per year
About Hays
Our many years of recruitment experience and our expert knowledge of the engineering job market make us a strong partner for engineers and technicians. We maintain close relationships with customers across all industries and therefore can provide engineering specialists with exciting projects and attractive job opportunities, drawing on your personal interests and experience. As your professional companion, we support you throughout the entire process, from the first contact to the first day on your new job – all this completely free of charge. Register now and look forward to many interesting and suitable positions and projects.
Staffing process for a permanent or temporary position
- Analysis of qualifications
- Telephone or personal interview
- Contact with customers
- Contract with Hays
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1. Analysis of qualifications
We will review your application documents and carry out a detailed analysis of your professional qualification.
Your contact at Hays
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