Regulatory Affairs Specialist with German and English language
Location: Poland
Type of work: Homebased
Responsibility for markets: Germany/ Switzerland/ Austria
You will be responsible for regulatory activities required at a country level for medicinal products, including maintenance and approvals, marketing authorization transfers, communication with the Health Authority, artwork approval etc. ensuring regulatory compliance in the applicable markets: Germany/ Switzerland/ Austria.
As part of the IQVIA Global Regulatory Affairs department, you will be working with our clients – global pharmaceutical companies.
Key Responsibilities
- Manage the local regulatory submission preparation in collaboration with internal and external stakeholders based on the agreed strategy for designated countries
- Submit submissions such as notifications/ renewals/ variations/ new applications filings/ MAH transfers to the local Health Authority and follow up on the local regulatory approval process for Germany/ Switzerland/ Austria
- Preparation, translations from English of local Product Labelling (e.g. SmPC, PIL), in German language for Germany/ Switzerland/ Austria
- Artwork and promotional materials review and approval in client systems
- Manage multiple pharmaceutical products
- Keep up to date on latest local pharmaceutical legislation, relevant guidelines and requirements
Qualifications
- Bachelor’s Degree in Life Sciences or professional equivalent
- 3+ years regulatory expertise of EU requirements for medicinal products including the creation of regulatory submission documents and coordinating delivery to submission plans, artwork review, communication with the Health Authority, in country-specific experience (Germany/ Switzerland/ Austria) would be benefit, but not required
- Experience with working in a large regulatory organization where some tasks are managed centrally and some at a local level
- Knowledge of local (Germany/ Switzerland/ Austria) pharmaceutical legislation, relevant guidelines and requirements would be a plus
- excellent organization and communication skills,
- ability to work to tight timelines
- Good team player
- Excellent written and verbal communication skills in English and German
- Strong computer skills, including MS Office applications, and preferably, experience with Regulatory Information management and artwork systems
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com